OZT · Balloon Aortic Valvuloplasty
Cardiovascular · 21 CFR 870.1255 · Class 2
Overview
| Product Code | OZT |
|---|---|
| Device Name | Balloon Aortic Valvuloplasty |
| Regulation | 21 CFR 870.1255 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible. (2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components. (3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal. (4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis. (5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.
In combination with the general controls of the FD&C Act, the NuMED NuCLEUS and NuCLEUS-X BAV Catheters are subject to the following special controls:
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro) | Dongguan TT Medical, Inc. | Mar 20, 2026 | SESE |
| K241562 | OutFlo Aortic Valve Dilatation Balloon Catheter | Disa Medinotec | Mar 11, 2025 | SESE |
| K240967 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | Jul 31, 2024 | SESE |
| K231814 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | Oct 12, 2023 | SESE |
| K220881 | INOUE BALLOON A | Toray Industries, Inc. | Dec 18, 2022 | SESE |
| K172932 | True Flow Valvuloplasty Perfusion Catheter | C.R. Bard, Inc. | Dec 13, 2017 | SESE |
| K152613 | True Flow Valvuloplasty Perfusion Catheter | C.R. Bard, Inc. | Jan 19, 2016 | SESE |
| K152150 | V8 Balloon Aortic Valvuloplasty Catheter | Intervalve, Inc. | Dec 18, 2015 | SESE |
| K150667 | True Dilatation Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | Jun 17, 2015 | SESE |
| K142083 | TRUE FLOW VALVULOPLASTY PERFUSION CATHETER | C.R. Bard, Inc. | Apr 17, 2015 | SESE |
| K150343 | V8 Transluminal BAV Catheter | Intervalve, Inc. | Apr 3, 2015 | SESE |
| K142199 | Ascendra Balloon Aortic Valvaloplasty Catheter | Edwards Lifesciences | Oct 29, 2014 | SESE |
| K141985 | TRUE BA V BALLOON VALVULOPLASTY CATHETER | C.R. Bard, Inc. | Sep 18, 2014 | SESE |
| K140241 | EDWARDS TRANSFEMORAL BALLOON CATHETER | Edwards Lifesciences, LLC | Jul 3, 2014 | SESE |
| K133607 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | Feb 11, 2014 | SESE |
| 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. | Dec 20, 2013 | SESE |
| K132728 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | Nov 22, 2013 | SESE |
| K123111 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | Jan 31, 2013 | SESE |
| K121083 | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA | Loma Vista Medical | Oct 11, 2012 | SESE |
| K122012 | Z-MED Z-MED II | NuMED, Inc. | Oct 4, 2012 | SESE |
Top Applicants
- C.R. Bard, Inc. — 5 clearances
- Intervalve, Inc. — 5 clearances
- Dongguan TT Medical, Inc. — 3 clearances
- NuMED, Inc. — 2 clearances
- Bard Peripheral Vascular, Inc. — 1 clearance
