510(k) K944668

SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS by Medtronics Interventional Vascular — Product Code DQY

K944668 is an FDA 510(k) premarket notification submitted by Medtronics Interventional Vascular for the device "SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS". The FDA issued a decision of Substantially Equivalent on March 3, 1995. 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
March 3, 1995
Date Received
September 13, 1994
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