TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
FDA 510(k) clearance K133569 · decided 2013-12-20
Clearance details
- K-number
- K133569
- Device name
- TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
- Applicant
- Bard Peripheral Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-20
- Decision date
- 2013-12-20
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- OZT
- Device class
- 2
- Regulation number
- 870.1255
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sunnyvale, CA, 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 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Fluency Plus Endovascular Stent Graft (P130029/S015) | Bard Peripheral Vascular, Inc. | 2026-06-22 |
| Venovo Venous Stent System (P180037/S015) | Bard Peripheral Vascular, Inc. | 2026-06-10 |
| LifeStent 5F Vascular Stent Systems (P070014/S069) | Bard Peripheral Vascular, Inc. | 2026-06-10 |
| Bard Fluency Plus Endovascular Stent Graft (P130029/S014) | Bard Peripheral Vascular, Inc. | 2026-06-10 |
| LifeStent 5F Vascular Stent System (P070014/S068) | Bard Peripheral Vascular, Inc. | 2026-05-15 |
| LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM (P070014/S067) | Bard Peripheral Vascular, Inc. | 2026-03-10 |
| LifeStent® Vascular Stent Systems (P070014/S066) | Bard Peripheral Vascular, Inc. | 2025-12-16 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S014) | Bard Peripheral Vascular, Inc. | 2025-09-29 |