510(k) K935738

MEDTRONIC GCIII CORONARY GUIDING CATHETER by Medtronics Interventional Vascular — Product Code DQY

K935738 is an FDA 510(k) premarket notification submitted by Medtronics Interventional Vascular for the device "MEDTRONIC GCIII CORONARY GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on May 4, 1994. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Medtronics Interventional Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1994
Date Received
December 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type