MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
FDA 510(k) clearance K020012 · decided 2002-01-29
Clearance details
- K-number
- K020012
- Device name
- MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
- Applicant
- Boston Scientific/Medi-Tech
- Decision
- Substantially Equivalent
- Date received
- 2002-01-03
- Decision date
- 2002-01-29
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, Renegade Fiber Braided Microcatheter, Peripheral Vascular Use, RX Only, recall (Z-2246-2009) | Boston Scientific Corporation | 2009-09-24 |