RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
FDA 510(k) clearance K140329 · decided 2014-05-15
Clearance details
- K-number
- K140329
- Device name
- RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2014-02-10
- Decision date
- 2014-05-15
- Days to decision
- 94 days
- Clearance type
- Special
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.