Ascendra Balloon Aortic Valvaloplasty Catheter
FDA 510(k) clearance K142199 · decided 2014-10-29
Clearance details
- K-number
- K142199
- Device name
- Ascendra Balloon Aortic Valvaloplasty Catheter
- Applicant
- Edwards Lifesciences
- Decision
- Substantially Equivalent
- Date received
- 2014-08-11
- Decision date
- 2014-10-29
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- OZT
- Device class
- 2
- Regulation number
- 870.1255
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Edwards Lifesciences
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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.