EDWARDS TRANSFEMORAL BALLOON CATHETER
FDA 510(k) clearance K140241 · decided 2014-07-03
Clearance details
- K-number
- K140241
- Device name
- EDWARDS TRANSFEMORAL BALLOON CATHETER
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-01-30
- Decision date
- 2014-07-03
- Days to decision
- 154 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
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|---|---|---|
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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 |
| V8 Transluminal BAV Catheter (K150343) | Intervalve, Inc. | 2015-04-03 |
Recalls involving this device
No recalls on record reference this clearance.