Circulatory Technology, Inc.
Oyster Bay, NY, US
Circulatory Technology, Inc. appears in FDA device records in Oyster Bay, NY. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 7 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Circulatory Technology, Inc. between 1994 and 2014. The busiest year on record is 1994, with 2. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140321 | INITARY BETTER BLADDER-PEDIATRIC | DTN | Substantially Equivalent | |
| K012942 | THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 | DTN | Substantially Equivalent | |
| K001822 | THE V-BAG | DTN | Substantially Equivalent | |
| K981284 | BETTER-BLADDER (BB) | DTN | Substantially Equivalent | |
| K964205 | BETTER-TUBING | DWF | Substantially Equivalent | |
| K964337 | BETTER-BLADDER (BB) | FIB | Substantially Equivalent | |
| K961594 | BETTER-VENTER | DWF | Substantially Equivalent | |
| K941492 | PRESSURE RELIEF VALVE | MNJ | Substantially Equivalent | |
| K942933 | PRESSURE INFUSION CUFF | KZD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1862-2021 | The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14 | The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow. | Class II | Open, Classified | |
| Z-1171-2018 | **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers) | The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow. | Class II | Terminated | |
| Z-0817-2018 | Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers) | The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow. | Class II | Terminated | |
| Z-2832-2016 | The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump. | The seal between the balloon and the housing may leak. | Class II | Terminated | |
| Z-0057-2017 | The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump. | Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm. | Class III | Terminated | |
| Z-2050-2016 | Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 | The seal between the balloon and the housing may leak. | Class II | Terminated | |
| Z-1323-2010 | The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284. | During an FDA inspection, it was discovered that the firm had conducted a silent recall of its Bigger Better Bladder device after receiving a complaint from a hospital that the device collapsed during a procedure thereby obstructing flow. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain