510(k) K935425

METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS by Medtronics Interventional Vascular — Product Code DQY

K935425 is an FDA 510(k) premarket notification submitted by Medtronics Interventional Vascular for the device "METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS". The FDA issued a decision of Substantially Equivalent on April 26, 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
April 26, 1994
Date Received
November 10, 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