CANYONS BI-DIRECTIONAL CHECK VALVE
FDA 510(k) clearance K954181 · decided 1995-11-29
Clearance details
- K-number
- K954181
- Device name
- CANYONS BI-DIRECTIONAL CHECK VALVE
- Applicant
- Canyon Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1995-09-06
- Decision date
- 1995-11-29
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- KYX
- Device class
- 1
- Regulation number
- 880.6430
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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.