510(k) K070380

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2007
Date Received
February 8, 2007
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