CANYONS BI-DIRECTIONAL CHECK VALVE— 510(k) K954181

Substantially Equivalent

Canyon Medical Products

FDA 510(k) clearance K954181 for CANYONS BI-DIRECTIONAL CHECK VALVE, Substantially Equivalent on 1995-11-29. Applicant: Canyon Medical Products.

Clearance details

Applicant: Canyon Medical Products
Product code: Code KYX
Advisory panel: General Hospital
Date received: 1995-09-06
Decision date: 1995-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KYX

product code KYX

Death: 3
Other: 8
Total: 11

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.