Home › Device types › OZT
Balloon Aortic Valvuloplasty
FDA product code OZT · Class 2 · Cardiovascular
294
Registered devices
367
Adverse events
2
Recalls
22
510(k) clearances
Devices with this code
Z-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCZ-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCZ-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCZ-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCV8 — INTERVALVE INCZ-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCZ-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCZ-MED II™ — B BRAUN INTERVENTIONAL SYSTEMS, INCNuCLEUS-X™ — B BRAUN INTERVENTIONAL SYSTEMS, INCZ-MED II™ — B BRAUN INTERVENTIONAL SYSTEMS, INCZ-MED II™ — B BRAUN INTERVENTIONAL SYSTEMS, INCZ-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCZ-MED II™ — B BRAUN INTERVENTIONAL SYSTEMS, INCV8 — INTERVALVE INCZ-MED II™ — B BRAUN INTERVENTIONAL SYSTEMS, INCZ-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCTRUE DILATATION — Bard Peripheral Vascular, Inc.INOUE BALLOON A — TORAY INDUSTRIES,INC.Z-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCVIDA® — Bard Peripheral Vascular, Inc.Z-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCV8 — INTERVALVE INCZ-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCZ-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-03-14 | InterValve Inc | Leak issues were discovered through accelerated age testing. |
| 2013-03-18 | Loma Vista Medical | Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device pe |
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