510(k) K903848

DIAGNOSTIC INTRASCULAR CATHETER by Applied Vascular Devices, Inc. — Product Code DQO

K903848 is an FDA 510(k) premarket notification submitted by Applied Vascular Devices, Inc. for the device "DIAGNOSTIC INTRASCULAR CATHETER". The FDA issued a decision of Substantially Equivalent on March 25, 1991. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Applied Vascular Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1991
Date Received
August 21, 1990
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