RENEGADE HI-FLO MICROCATHETER
FDA 510(k) clearance K000177 · decided 2000-04-07
Clearance details
- K-number
- K000177
- Device name
- RENEGADE HI-FLO MICROCATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2000-01-20
- Decision date
- 2000-04-07
- Days to decision
- 78 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 Neuro Renegade Hi-Flo Microcatheter, 150cm/20cm; Rx Only; Model Nu recall (Z-0357-2011) | Boston Scientific Corporation | 2010-11-15 |
| Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with recall (Z-2244-2009) | Boston Scientific Corporation | 2009-09-24 |
| Boston Scientific Renegade" Hi Flo Microcatheter (neurovascular use) REF 18-288OUS, Steril recall (Z-2245-2009) | Boston Scientific Corporation | 2009-09-24 |
| Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catal recall (Z-0109-2008) | Boston Scientific Corporation | 2007-10-31 |
| Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990 recall (Z-0122-2007) | Boston Scientific Corporation | 2006-11-01 |