510(k) K081573

MEDTRONIC EXPORT AP CATHETER by Medtronic Vascular — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2008
Date Received
June 5, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type