V8 TRANSLUMINAL BAV CATHETER
FDA 510(k) clearance K133607 · decided 2014-02-11
Clearance details
- K-number
- K133607
- Device name
- V8 TRANSLUMINAL BAV CATHETER
- Applicant
- Intervalve, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-25
- Decision date
- 2014-02-11
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- OZT
- Device class
- 2
- Regulation number
- 870.1255
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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| INOUE BALLOON A (K220881) | Toray Industries, Inc. | 2022-12-18 |
| True Flow Valvuloplasty Perfusion Catheter (K172932) | C.R. Bard, Inc. | 2017-12-13 |
| True Flow Valvuloplasty Perfusion Catheter (K152613) | C.R. Bard, Inc. | 2016-01-19 |
| V8 Balloon Aortic Valvuloplasty Catheter (K152150) | Intervalve, Inc. | 2015-12-18 |
| True Dilatation Balloon Valvuloplasty Catheter (K150667) | C.R. Bard, Inc. | 2015-06-17 |
| TRUE FLOW VALVULOPLASTY PERFUSION CATHETER (K142083) | C.R. Bard, Inc. | 2015-04-17 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C recall (Z-1621-2014) | InterValve Inc | 2014-05-15 |