510(k) K954181

CANYONS BI-DIRECTIONAL CHECK VALVE by Canyon Medical Products — Product Code KYX

K954181 is an FDA 510(k) premarket notification submitted by Canyon Medical Products for the device "CANYONS BI-DIRECTIONAL CHECK VALVE". The FDA issued a decision of Substantially Equivalent on November 29, 1995. The device falls under product code KYX (Dispenser, Liquid Medication), a Class I device regulated under 21 CFR 880.6430. Canyon Medical Products has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1995
Date Received
September 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dispenser, Liquid Medication
Device Class
Class I
Regulation Number
880.6430
Review Panel
HO
Submission Type