True Dilatation Balloon Valvuloplasty Catheter
FDA 510(k) clearance K150667 · decided 2015-06-17
Clearance details
- K-number
- K150667
- Device name
- True Dilatation Balloon Valvuloplasty Catheter
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-16
- Decision date
- 2015-06-17
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- OZT
- Device class
- 2
- Regulation number
- 870.1255
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tempe, AZ, 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.
| Record | Firm | Date |
|---|---|---|
| KardiaPSI Balloon Catheter (K253855) | Intervention Tech, Inc. ; dba Corvention | 2026-05-06 |
| Valvuloplasty Balloon Catheter (ValvuloPro) (K260437) | Dongguan TT Medical, Inc. | 2026-03-20 |
| 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 FLOW VALVULOPLASTY PERFUSION CATHETER (K142083) | C.R. Bard, Inc. | 2015-04-17 |
| V8 Transluminal BAV Catheter (K150343) | Intervalve, Inc. | 2015-04-03 |
| Ascendra Balloon Aortic Valvaloplasty Catheter (K142199) | Edwards Lifesciences | 2014-10-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |