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

Name: FDA 510(k) clearance K954181
Creator: U.S. Food and Drug Administration
Published: 1995-11-29

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. Device class: 1.

Clearance details

Applicant: Canyon Medical Products
Product code: Code KYX
Device class: Class 1
Regulation: 21 CFR 880.6430
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 ↗

Recent devices under product code KYX

view all

K143177 — KleenGel Dispenser2015-09-14
K980109 — CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER1998-08-18
K830571 — BOTTLE ADAPTER1983-03-24
K801008 — MULTI-AD FLUID DISPENSING PUMP MP-30001980-06-02
K800362 — FLUID DISPENSING SYSTEM1980-03-12

More clearances from Canyon Medical Products

view all

K897026 — CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.1990-02-26
K874899 — CANYON MEDICAL FEMORAL BYPASS CANNULAE1988-02-18

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.