Panels › Cardiovascular › Product code OZT · Class 2
Balloon Aortic Valvuloplasty
Regulation 870.1255
2510(k)s in 12 months (22 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OZT
| Company | 510(k)s | Recalls |
|---|---|---|
| Intervalve, Inc. | 5 | 1 |
| C.R. Bard, Inc. | 5 | 0 |
| Dongguan TT Medical, Inc. | 3 | 0 |
| Edwards Lifesciences | 2 | 0 |
| Loma Vista Medical | 1 | 1 |
| NuMED, Inc. | 2 | 0 |
| Bard Peripheral Vascular, Inc. | 1 | 0 |
| Disa Medinotec | 1 | 0 |
| Intervention Tech, Inc. ; dba Corvention | 1 | 0 |
| Toray Industries, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 6, 2026 | K253855 | KardiaPSI Balloon Catheter Intervention Tech, Inc. ; dba Corvention | OZT |
| Mar 20, 2026 | K260437 | Valvuloplasty Balloon Catheter (ValvuloPro) Dongguan TT Medical, Inc., CN | OZT |
| Mar 11, 2025 | K241562 | OutFlo Aortic Valve Dilatation Balloon Catheter Disa Medinotec, ZA | OZT |
| Jul 31, 2024 | K240967 | ValvuloPro Valvuloplasty Balloon Catheter Dongguan TT Medical, Inc., CN | OZT |
| Oct 12, 2023 | K231814 | ValvuloPro Valvuloplasty Balloon Catheter Dongguan TT Medical, Inc., CN | OZT |
| Dec 18, 2022 | K220881 | INOUE BALLOON A Toray Industries, Inc., JP | OZT |
| Dec 13, 2017 | K172932 | True Flow Valvuloplasty Perfusion Catheter C.R. Bard, Inc. | OZT |
| Jan 19, 2016 | K152613 | True Flow Valvuloplasty Perfusion Catheter C.R. Bard, Inc. | OZT |
| Dec 18, 2015 | K152150 | V8 Balloon Aortic Valvuloplasty Catheter Intervalve, Inc. | OZT |
| Jun 17, 2015 | K150667 | True Dilatation Balloon Valvuloplasty Catheter C.R. Bard, Inc. | OZT |
| Apr 17, 2015 | K142083 | TRUE FLOW VALVULOPLASTY PERFUSION CATHETER C.R. Bard, Inc. | OZT |
| Apr 3, 2015 | K150343 | V8 Transluminal BAV Catheter Intervalve, Inc. | OZT |
| Oct 29, 2014 | K142199 | Ascendra Balloon Aortic Valvaloplasty Catheter Edwards Lifesciences | OZT |
| Sep 18, 2014 | K141985 | TRUE BA V BALLOON VALVULOPLASTY CATHETER C.R. Bard, Inc. | OZT |
| Jul 3, 2014 | K140241 | EDWARDS TRANSFEMORAL BALLOON CATHETER Edwards Lifesciences, LLC | OZT |
| Feb 11, 2014 | K133607 | V8 TRANSLUMINAL BAV CATHETER Intervalve, Inc. | OZT |
| Dec 20, 2013 | 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. | OZT |
| Nov 22, 2013 | K132728 | V8 TRANSLUMINAL BAV CATHETER Intervalve, Inc. | OZT |
| Jan 31, 2013 | K123111 | V8 TRANSLUMINAL BAV CATHETER Intervalve, Inc. | OZT |
| Oct 11, 2012 | K121083 | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA Loma Vista Medical | OZT |
| Oct 4, 2012 | K122012 | Z-MED Z-MED II NuMED, Inc. | OZT |
| Jun 11, 2012 | DEN080015 | NUCLEUS-X PTV CATHETER NuMED, Inc. | OZT |
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