510(k) K933496

MAXIMA FILTERED HARDSHELL RESERVIOR by Medtronic Vascular — Product Code DTP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1993
Date Received
July 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Defoamer, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4230
Review Panel
CV
Submission Type