FDA Product Code
FDA Product Code OZT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1255
510(k) Clearances — 22 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253855 | KardiaPSI Balloon Catheter | Intervention Tech, Inc. ; dba Corvention | 2026-05-06 | Traditional | PDF ↗ |
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro) | Dongguan TT Medical, Inc. | 2026-03-20 | Special | PDF ↗ |
| K241562 | OutFlo Aortic Valve Dilatation Balloon Catheter | Disa Medinotec | 2025-03-11 | Traditional | PDF ↗ |
| K240967 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | 2024-07-31 | Special | PDF ↗ |
| K231814 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | 2023-10-12 | Traditional | PDF ↗ |
| K220881 | INOUE BALLOON A | Toray Industries, Inc. | 2022-12-18 | Traditional | PDF ↗ |
| K172932 | True Flow Valvuloplasty Perfusion Catheter | C.R. Bard, Inc. | 2017-12-13 | Traditional | PDF ↗ |
| K152613 | True Flow Valvuloplasty Perfusion Catheter | C.R. Bard, Inc. | 2016-01-19 | Traditional | PDF ↗ |
| K152150 | V8 Balloon Aortic Valvuloplasty Catheter | Intervalve, Inc. | 2015-12-18 | Traditional | PDF ↗ |
| K150667 | True Dilatation Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | 2015-06-17 | Traditional | PDF ↗ |
| K142083 | TRUE FLOW VALVULOPLASTY PERFUSION CATHETER | C.R. Bard, Inc. | 2015-04-17 | Traditional | PDF ↗ |
| K150343 | V8 Transluminal BAV Catheter | Intervalve, Inc. | 2015-04-03 | Special | PDF ↗ |
| K142199 | Ascendra Balloon Aortic Valvaloplasty Catheter | Edwards Lifesciences | 2014-10-29 | Traditional | PDF ↗ |
| K141985 | TRUE BA V BALLOON VALVULOPLASTY CATHETER | C.R. Bard, Inc. | 2014-09-18 | Traditional | PDF ↗ |
| K140241 | EDWARDS TRANSFEMORAL BALLOON CATHETER | Edwards Lifesciences, LLC | 2014-07-03 | Traditional | PDF ↗ |
| K133607 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2014-02-11 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| K132728 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2013-11-22 | Special | PDF ↗ |
| K123111 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2013-01-31 | Traditional | PDF ↗ |
| K121083 | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA | Loma Vista Medical | 2012-10-11 | Traditional | PDF ↗ |
| K122012 | Z-MED Z-MED II | NuMED, Inc. | 2012-10-04 | Traditional | PDF ↗ |
| DEN080015 | NUCLEUS-X PTV CATHETER | NuMED, Inc. | 2012-06-11 | Post-NSE | — |
Product code OZT · Class II · Cardiovascular. Data: openFDA.