Z-Med Z-Med II
FDA 510(k) K122012 · NuMED, Inc.
510(k) numberK122012
Submission
- Device name
- Z-Med Z-Med II
- Applicant
- NuMED, Inc.
Hopkinton, NY, US - Received
- July 10, 2012
- Decision date
- October 4, 2012
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K213915 | BIB Stent Placement CatheterNVM · Special | 01/12/2022SE |
| K211910 | Z-6 Atrioseptostomy CatheterDXF · Special | 07/19/2021SE |
| K211134 | BIB Stent Placement CatheterNVM · Special | 05/27/2021SE |
| K190974 | D'Vill IntroducerDYB · Special | 05/14/2019SE |
| K171206 | D'Vill IntroducerDYB · Traditional | 10/20/2017SE |
| K161451 | BIB Stent Placement CatheterNVM · Traditional | 09/22/2016SE |
| K160598 | REBOA Balloon CatheterMJN · Traditional | 06/20/2016SE |
| K160889 | BIB Stent Placement CatheterNVM · Traditional | 05/20/2016SE |
| K131869 | Pts-X Sizing Balloon CatheterMJN · Special | 08/08/2013SE |
| K121859 | Tyshak NucleusDQY · Special | 08/31/2012SE |
Questions and answers
When was Z-Med Z-Med II cleared by the FDA?
Z-Med Z-Med II (K122012) received a 510(k) decision of Substantially Equivalent on October 4, 2012, 86 days after the submission was received.
What is the product code of K122012?
The FDA product code is OZT – Balloon Aortic Valvuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.1255.