CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.
FDA 510(k) clearance K897026 · decided 1990-02-26
Clearance details
- K-number
- K897026
- Device name
- CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.
- Applicant
- Canyon Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1989-12-19
- Decision date
- 1990-02-26
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.