510(k) K980762

PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE by Pall Corp. — Product Code DTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1998
Date Received
February 27, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class
Class II
Regulation Number
870.4260
Review Panel
CV
Submission Type