PENUMBRA EMBOLIZATION COIL SYSTEM
FDA 510(k) clearance K103305 · decided 2011-01-26
Clearance details
- K-number
- K103305
- Device name
- PENUMBRA EMBOLIZATION COIL SYSTEM
- Applicant
- Penumbra, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-09
- Decision date
- 2011-01-26
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distri recall (Z-1906-2011) | Penumbra Inc. | 2011-04-12 |