MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
FDA 510(k) clearance K083646 · decided 2009-01-02
Clearance details
- K-number
- K083646
- Device name
- MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
- Applicant
- Micrus Endovascular Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-12-09
- Decision date
- 2009-01-02
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consis recall (Z-0845-2011) | Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131 | 2011-01-03 |