510(k) K033085

PORTACLAMP by Cardio Life Research, S.A. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2004
Date Received
September 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type