510(k) K140241
- Device
- EDWARDS TRANSFEMORAL BALLOON CATHETER
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- 510(k) number
- K140241
- Product code
- OZT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-03
- Date received
- 2014-01-30
- Regulation
- 870.1255
- Classification name
- Balloon Aortic Valvuloplasty
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ERIC CARRIER
- Address
- One Edwards Way Irvine CA US 92663 92663
FDA Registration Numbers#
- 9614758
- 1318694
- 2015691
- 1313046
- 2528981
- 1649869
- 9618000
- 3011088743
- 3002244583
- 2020394
- 1721676
- 9617592
- 3021140368
- 3008500478
- 3013152301
- 1646831
- 2011171
- 3006082230
- 9612812
- 1018233
- 3029663075
- 3021230784
Source Documents#
Other 510(k) Records For Product Code OZT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253855 | KardiaPSI Balloon Catheter | Intervention Tech, Inc. ; dba Corvention | 2026-05-06 |
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro) | Dongguan TT Medical, Inc. | 2026-03-20 |
| K241562 | OutFlo Aortic Valve Dilatation Balloon Catheter | Disa Medinotec | 2025-03-11 |
| K240967 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | 2024-07-31 |
| K231814 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | 2023-10-12 |
| K220881 | INOUE BALLOON A | Toray Industries, Inc. | 2022-12-18 |
| K172932 | True Flow Valvuloplasty Perfusion Catheter | C.R. Bard, Inc. | 2017-12-13 |
| K152613 | True Flow Valvuloplasty Perfusion Catheter | C.R. Bard, Inc. | 2016-01-19 |
| K152150 | V8 Balloon Aortic Valvuloplasty Catheter | Intervalve, Inc. | 2015-12-18 |
| K150667 | True Dilatation Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | 2015-06-17 |
| K142083 | TRUE FLOW VALVULOPLASTY PERFUSION CATHETER | C.R. Bard, Inc. | 2015-04-17 |
| K150343 | V8 Transluminal BAV Catheter | Intervalve, Inc. | 2015-04-03 |
| K142199 | Ascendra Balloon Aortic Valvaloplasty Catheter | Edwards Lifesciences | 2014-10-29 |
| K141985 | TRUE BA V BALLOON VALVULOPLASTY CATHETER | C.R. Bard, Inc. | 2014-09-18 |
| K133607 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2014-02-11 |
Legacy Summary#
summary
FDA Review#
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