Product code OZT
- Device name
- Balloon Aortic Valvuloplasty
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1255
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K140241 | EDWARDS TRANSFEMORAL BALLOON CATHETER | Edwards Lifesciences, LLC | 2014-07-03 |
| K133607 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2014-02-11 |
| K133569 | TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM | Bard Peripheral Vascular, Inc. | 2013-12-20 |
| K132728 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2013-11-22 |
| K123111 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2013-01-31 |
| K121083 | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA | Loma Vista Medical | 2012-10-11 |
| K122012 | Z-MED Z-MED II | NuMED, Inc. | 2012-10-04 |
| DEN080015 | NUCLEUS-X PTV CATHETER | NuMED, Inc. | 2012-06-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04046964329098 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964335525 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964335471 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964335440 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964335044 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333286 | Z-MED II™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333262 | Z-MED II™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964333248 | Z-MED II™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964329494 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964329395 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964329319 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964329234 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964329159 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964329135 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964329111 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964326790 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328961 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328947 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328909 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328824 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328800 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328787 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328763 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328701 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328688 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328664 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328640 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328626 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964328565 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |
| 04046964326813 | Z-MED™ | B BRAUN INTERVENTIONAL SYSTEMS, INC | 2016-08-09 |