Company ยท US
Circulatory Technology, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2014. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 2014 | K140321 | INITARY BETTER BLADDER-PEDIATRIC Circulatory Technology, Inc. | DTN |
| Nov 5, 2001 | K012942 | THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 Circulatory Technology, Inc. | DTN |
| Jul 7, 2000 | K001822 | THE V-BAG Circulatory Technology, Inc. | DTN |
| Aug 12, 1998 | K981284 | BETTER-BLADDER (BB) Circulatory Technology, Inc. | DTN |
| Apr 8, 1998 | K964205 | BETTER-TUBING Circulatory Technology, Inc. | DWF |
| May 23, 1997 | K964337 | BETTER-BLADDER (BB) Circulatory Technology, Inc. | FIB |
| Sep 5, 1996 | K961594 | BETTER-VENTER Circulatory Technology, Inc. | DWF |
| Oct 26, 1994 | K941492 | PRESSURE RELIEF VALVE Circulatory Technology, Inc. | MNJ |
| Aug 25, 1994 | K942933 | PRESSURE INFUSION CUFF Circulatory Technology, Inc. | KZD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2021 | Circulatory Technology Inc. The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14 Open, Classified |
DTN | K981284 |
| Mar 1, 2018 | Circulatory Technology Inc **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) Terminated |
DTN | K981284 |
| Mar 1, 2018 | Circulatory Technology Inc Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers) Terminated |
DTN | K981284 |
| Oct 7, 2016 | Circulatory Technology Inc 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. Terminated |
DTN | K981284 |
| Jul 1, 2016 | Circulatory Technology Inc 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 Terminated |
DTN | K981284 |
| Mar 3, 2016 | Circulatory Technology Inc Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 Terminated |
DTN | K981284 |
| Apr 13, 2010 | Circulatory Technology Inc 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- Terminated |
DTN | K981284 |