Access Scientific, Inc.
San Diego, CA, US
Access Scientific, Inc. appears in FDA device records in San Diego, CA. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 14 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Access Scientific, Inc. between 2008 and 2019. The busiest year on record is 2011, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 2 |
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model | DYB | Substantially Equivalent | |
| K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology | DQY | Substantially Equivalent | |
| K182243 | The CVC WAND Safety Introducer with Valved Peelable Sheath | DYB | Substantially Equivalent | |
| K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model | DYB | Substantially Equivalent | |
| K131148 | THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH | DYB | Substantially Equivalent | |
| K131300 | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | DYB | Substantially Equivalent | |
| K121748 | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL | DYB | Substantially Equivalent | |
| K111417 | THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | DYB | Substantially Equivalent | |
| K111138 | THE PICC WAND (R) PEELABLE SAFETY INTRODUCER | DYB | Substantially Equivalent | |
| K101422 | THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | DYB | Substantially Equivalent | |
| K101150 | PICC WAND PEELABLE SAFETY INTRODUCER | DYB | Substantially Equivalent | |
| K093022 | THE PICC WAND PEELABLE SAFETY INTRODUCER | DYB | Substantially Equivalent | |
| K090372 | THE WAND MICROACCESS SAFETY INTRODUCER | DYB | Substantially Equivalent | |
| K081697 | THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 | DYB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2550-2020 | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure. | Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance. | Class III | Terminated | |
| Z-1983-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-1982-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-1981-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-1980-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-1979-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-1978-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/10859821006220 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-1977-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/10859821006206 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-1976-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-1975-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-1974-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-1973-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-1972-2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Terminated | |
| Z-2254-2013 | POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously. | Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain