Akcess Medical Products, Inc.
New Brunswick, NJ, US
Akcess Medical Products, Inc. appears in FDA device records in New Brunswick, NJ. FDA records list 36 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 36
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 36 510(k) clearances for Akcess Medical Products, Inc. between 1989 and 1994. The busiest year on record is 1989, with 13. The most recent is 1994, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 13 |
| 1990 | 7 |
| 1991 | 6 |
| 1992 | 4 |
| 1994 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K926374 | SILICONE CATHETER REPAIR KITS | KOC | Unknown | |
| K925819 | AKCESS0CATH KIT | LFJ | Substantially Equivalent | |
| K925818 | AKCESS-CATH | LFJ | Substantially Equivalent | |
| K930630 | RIGHT ATRIAL CATHETER | LJS | Substantially Equivalent for Some Indications | |
| K931120 | COAXIAL ACUTE CATHETER | LFJ | Substantially Equivalent | |
| K920634 | SPLITTABLE SHEATH INTRODUCER SET | LFJ | Substantially Equivalent | |
| K914936 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET | LFK | Unknown | |
| K920331 | RIGHT ATRIAL CATHETER KITS | DQY | Unknown | |
| K914826 | AKCESS-CATH KIT | LFJ | Unknown | |
| K915215 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS | LFK | Unknown | |
| K911333 | RIGHT ATRIAL CATHETERS | DQY | Substantially Equivalent | |
| K910641 | INTRODUCER NEEDLES | KOC | Substantially Equivalent | |
| K910572 | INJECTION CAPS | FOZ | Substantially Equivalent | |
| K910502 | VESSEL DILATORS | FKA | Substantially Equivalent | |
| K910501 | PERMANENT SILICONE CATHETERS | LFJ | Substantially Equivalent | |
| K910321 | Y ADAPTOR | KOC | Substantially Equivalent | |
| K904139 | SINGLE LUMEN CATHETER KITS | LFJ | Unknown | |
| K904140 | SINGLE LUMEN CATHETERS, MODIFICATION | LFJ | Substantially Equivalent | |
| K904433 | DUAL LUMEN NEEDLES | LBW | Substantially Equivalent | |
| K902203 | TENCKHOFF PERITONEAL DIALYSIS KIT | FJG | Unknown | |
| K902101 | PERITONEAL CATHETERS | FJS | Substantially Equivalent | |
| K901061 | SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000 | LFJ | Substantially Equivalent | |
| K900803 | DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S | LFJ | Substantially Equivalent | |
| K893679 | SHUNT CONNECTORS | FJQ | Substantially Equivalent | |
| K893478 | DA-16 AND DA-24 SHUNT ADAPTERS | FKN | Substantially Equivalent | |
| K893438 | T SERIES VESSEL TIPS | FKW | Substantially Equivalent | |
| K891755 | DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K | LFJ | Substantially Equivalent | |
| K891753 | DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800 | LFJ | Substantially Equivalent | |
| K892887 | ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA | FIQ | Substantially Equivalent | |
| K892667 | SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 | FKN | Substantially Equivalent | |
| K892666 | SAF-T-SHUNT, S-300 SERIES | FIQ | Substantially Equivalent | |
| K892663 | S-100 ALLEN-BROWN SHUNT | FIQ | Substantially Equivalent | |
| K891764 | FC-101 FEMORAL CATHETER GUIDE WIRE | LFK | Substantially Equivalent | |
| K891763 | FC-100 FEMORAL CATHETER | LFK | Substantially Equivalent | |
| K891754 | DC-4 SHUNT INFUSION T | FKB | Substantially Equivalent | |
| K891752 | DA-46 FLUID BARRIER | FIB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- FKNAdaptor, Shunt
- FIQCannula, A-V Shunt
- LFKCatheter, Femoral
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- DQYCatheter, Percutaneous
- FJSCatheter, Peritoneal, Long-Term Indwelling
- LFJCatheter, Subclavian
- FKBConnector, Blood Tubing, Infusion T
- FJQConnector, Shunt
- FJGDialyzer, Parallel Flow
- FKADilator, Vessel
- FIBProtector, Transducer, Dialysis
- LBWSet, Dialysis, Single Needle (Co-Axial Flow)
- FKWTip, Vessel
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain