510(k) K902856

BARD FILTERED CARDIOTOMY RESERVOIR by C.R. Bard, Inc. — Product Code DTP

K902856 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD FILTERED CARDIOTOMY RESERVOIR". The FDA issued a decision of Substantially Equivalent on September 27, 1990. The device falls under product code DTP (Defoamer, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4230. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1990
Date Received
June 29, 1990
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