V8 TRANSLUMINAL BAV CATHETER
FDA 510(k) clearance K123111 · decided 2013-01-31
Clearance details
- K-number
- K123111
- Device name
- V8 TRANSLUMINAL BAV CATHETER
- Applicant
- Intervalve, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-10-03
- Decision date
- 2013-01-31
- Days to decision
- 120 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| KardiaPSI Balloon Catheter (K253855) | Intervention Tech, Inc. ; dba Corvention | 2026-05-06 |
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| OutFlo Aortic Valve Dilatation Balloon Catheter (K241562) | Disa Medinotec | 2025-03-11 |
| ValvuloPro Valvuloplasty Balloon Catheter (K240967) | Dongguan TT Medical, Inc. | 2024-07-31 |
| ValvuloPro Valvuloplasty Balloon Catheter (K231814) | Dongguan TT Medical, Inc. | 2023-10-12 |
| 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 |
| V8 Transluminal BAV Catheter (K150343) | Intervalve, Inc. | 2015-04-03 |
Recalls involving this device
No recalls on record reference this clearance.