510(k) K980973

MEDTRONIC ANGIOGRAPHIC CATHETER by Medtronics Interventional Vascular — Product Code DQO

K980973 is an FDA 510(k) premarket notification submitted by Medtronics Interventional Vascular for the device "MEDTRONIC ANGIOGRAPHIC CATHETER". The FDA issued a decision of Substantially Equivalent on December 10, 1998. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Medtronics Interventional Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1998
Date Received
March 16, 1998
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