BETTER-BLADDER (BB)
FDA 510(k) clearance K981284 · decided 1998-08-12
Clearance details
- K-number
- K981284
- Device name
- BETTER-BLADDER (BB)
- Applicant
- Circulatory Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-08
- Decision date
- 1998-08-12
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- DTN
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Oyster Bay, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, recall (Z-0817-2018) | Circulatory Technology Inc | 2018-03-01 |
| **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood recall (Z-1171-2018) | Circulatory Technology Inc | 2018-03-01 |
| The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively recall (Z-0057-2017) | Circulatory Technology Inc | 2016-10-07 |
| The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single recall (Z-1323-2010) | Circulatory Technology Inc | 2010-04-13 |