COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
FDA 510(k) clearance K991102 · decided 1999-06-09
Clearance details
- K-number
- K991102
- Device name
- COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
- Applicant
- Guidant Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-01
- Decision date
- 1999-06-09
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- DTL
- Device class
- 2
- Regulation number
- 870.4290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For us recall (Z-2792-2011) | Abbott Vascular | 2011-07-12 |