RENEGADE FIBER BRAIDED MICROCATHETER
FDA 510(k) clearance K973645 · decided 1997-11-19
Clearance details
- K-number
- K973645
- Device name
- RENEGADE FIBER BRAIDED MICROCATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1997-09-24
- Decision date
- 1997-11-19
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- 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 brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model N recall (Z-0358-2011) | Boston Scientific Corporation | 2010-11-15 |
| Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M0 recall (Z-0177-2007) | Boston Scientific Target | 2006-11-14 |