OPTIV ANTAGE DH POWER INJECTION SYSTEM
FDA 510(k) clearance K042744 · decided 2004-11-30
Clearance details
- K-number
- K042744
- Device name
- OPTIV ANTAGE DH POWER INJECTION SYSTEM
- Applicant
- Mallinckrodt Inc., Liebel-Flarsheim Business
- Decision
- Substantially Equivalent
- Date received
- 2004-10-04
- Decision date
- 2004-11-30
- Days to decision
- 57 days
- Clearance type
- Special
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OptiVantage DH Power Injection System. recall (Z-0288-2007) | Mallinckrodt Inc | 2006-12-16 |