510(k) K932218

CARDIAC CATH OR ANGIOGRAPHIC TRAYS by Associated Medical Products Co. — Product Code DQO

K932218 is an FDA 510(k) premarket notification submitted by Associated Medical Products Co. for the device "CARDIAC CATH OR ANGIOGRAPHIC TRAYS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on August 27, 1993. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Associated Medical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
August 27, 1993
Date Received
May 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type