True Ba V Balloon Valvuloplasty Catheter
FDA 510(k) K141985 · C.R. Bard, Inc.
510(k) numberK141985
Submission
- Device name
- True Ba V Balloon Valvuloplasty Catheter
- Applicant
- C.R. Bard, Inc.
Tempe, AZ, US - Received
- July 22, 2014
- Decision date
- September 18, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OZT – Balloon Aortic Valvuloplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1255
- Specialty
- Cardiovascular
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Other 510(k)s with product code OZT
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|---|---|---|---|
| K253855 | KardiaPSI Balloon CatheterOZT · Traditional | Intervention Tech, Inc. ; dba Corvention | 05/06/2026SE |
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro)OZT · Special | Dongguan TT Medical, Inc. | 03/20/2026SE |
| K241562 | OutFlo Aortic Valve Dilatation Balloon CatheterOZT · Traditional | Disa Medinotec | 03/11/2025SE |
| K240967 | ValvuloPro Valvuloplasty Balloon CatheterOZT · Special | Dongguan TT Medical, Inc. | 07/31/2024SE |
| K231814 | ValvuloPro Valvuloplasty Balloon CatheterOZT · Traditional | Dongguan TT Medical, Inc. | 10/12/2023SE |
| K220881 | Inoue Balloon aOZT · Traditional | Toray Industries, Inc. | 12/18/2022SE |
| K172932 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | C.R. Bard, Inc. | 12/13/2017SE |
| K152613 | True Flow Valvuloplasty Perfusion CatheterOZT · Traditional | C.R. Bard, Inc. | 01/19/2016SE |
| K152150 | V8 Balloon Aortic Valvuloplasty CatheterOZT · Traditional | Intervalve, Inc. | 12/18/2015SE |
| K150667 | True Dilatation Balloon Valvuloplasty CatheterOZT · Traditional | C.R. Bard, Inc. | 06/17/2015SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was True Ba V Balloon Valvuloplasty Catheter cleared by the FDA?
True Ba V Balloon Valvuloplasty Catheter (K141985) received a 510(k) decision of Substantially Equivalent on September 18, 2014, 58 days after the submission was received.
What is the product code of K141985?
The FDA product code is OZT – Balloon Aortic Valvuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.1255.