OZ POWER SYRINGE
FDA 510(k) clearance K973334 · decided 1998-04-03
Clearance details
- K-number
- K973334
- Device name
- OZ POWER SYRINGE
- Applicant
- Cardiovascular Innovations
- Decision
- Substantially Equivalent
- Date received
- 1997-09-04
- Decision date
- 1998-04-03
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedu recall (Z-0008-2008) | Lemaitre Vascular, Inc. | 2007-10-04 |