510(k) K022145

OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 by LeMaitre Vascular, Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2003
Date Received
July 2, 2002
Clearance Type
Traditional
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