Circulatory Technology Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 9
- Inspections
- 7
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1862-2021 | Class II | The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass c | April 27, 2021 |
| Z-0817-2018 | Class II | Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) a | September 22, 2017 |
| Z-1171-2018 | Class II | **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; | September 22, 2017 |
| Z-0057-2017 | Class III | The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the | July 1, 2016 |
| Z-2832-2016 | Class II | The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that | July 1, 2016 |
| Z-2050-2016 | Class II | Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 | March 3, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140321 | INITARY BETTER BLADDER-PEDIATRIC | April 17, 2014 |
| K012942 | THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX | November 5, 2001 |
| K001822 | THE V-BAG | July 7, 2000 |
| K981284 | BETTER-BLADDER (BB) | August 12, 1998 |
| K964205 | BETTER-TUBING | April 8, 1998 |
| K964337 | BETTER-BLADDER (BB) | May 23, 1997 |
| K961594 | BETTER-VENTER | September 5, 1996 |
| K941492 | PRESSURE RELIEF VALVE | October 26, 1994 |
| K942933 | PRESSURE INFUSION CUFF | August 25, 1994 |