FDA 510(k) Applications for Medical Device Product Code "OZT"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K133569 | BARD PERIPHERAL VASCULAR, INC. | TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM | 12/20/2013 |
| K152613 | C. R. BARD, INC. | True Flow Valvuloplasty Perfusion Catheter | 01/19/2016 |
| K172932 | C. R. Bard, Inc. | True Flow Valvuloplasty Perfusion Catheter | 12/13/2017 |
| K141985 | C.R. BARD, INC. | TRUE BA V BALLOON VALVULOPLASTY CATHETER | 09/18/2014 |
| K150667 | C.R. Bard, Inc. | True Dilatation Balloon Valvuloplasty Catheter | 06/17/2015 |
| K142083 | C.R. BARD, INC. | TRUE FLOW VALVULOPLASTY PERFUSION CATHETER | 04/17/2015 |
| K142199 | EDWARDS LIFESCIENCES | Ascendra Balloon Aortic Valvaloplasty Catheter | 10/29/2014 |
| K140241 | EDWARDS LIFESCIENCES, LLC. | EDWARDS TRANSFEMORAL BALLOON CATHETER | 07/03/2014 |
| K133607 | INTERVALVE, INC | V8 TRANSLUMINAL BAV CATHETER | 02/11/2014 |
| K123111 | INTERVALVE, INC | V8 TRANSLUMINAL BAV CATHETER | 01/31/2013 |
| K132728 | INTERVALVE, INC | V8 TRANSLUMINAL BAV CATHETER | 11/22/2013 |
| K152150 | InterValve, Inc. | V8 Balloon Aortic Valvuloplasty Catheter | 12/18/2015 |
| K150343 | InterValve, Inc. | V8 Transluminal BAV Catheter | 04/03/2015 |
| K121083 | LOMA VISTA MEDICAL | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA | 10/11/2012 |
| DEN080015 | NUMED, INC. | NUCLEUS-X PTV CATHETER | 06/11/2012 |
| K122012 | NUMED, INC. | Z-MED Z-MED II | 10/04/2012 |
| K220881 | Toray Industries, Inc. | INOUE BALLOON A | 12/18/2022 |
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