GUIDER SOFTIP GUIDING CATHETER XF 5F
FDA 510(k) clearance K010853 · decided 2001-04-18
Clearance details
- K-number
- K010853
- Device name
- GUIDER SOFTIP GUIDING CATHETER XF 5F
- Applicant
- Boston Scientific, Target
- Decision
- Substantially Equivalent
- Date received
- 2001-03-21
- Decision date
- 2001-04-18
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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