DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.

Suction Control, Intracardiac, Cardiopulmonary Bypass

BAXTER BENTLEY LABORATORIES, INC.

The following data is part of a premarket notification filed by Baxter Bentley Laboratories, Inc. with the FDA for Duraflo Ii Heparin Treated Suction Wands Var. Mod..

Pre-market Notification Details

Device IDK905311
510k NumberK905311
Device Name:DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.
ClassificationSuction Control, Intracardiac, Cardiopulmonary Bypass
Applicant BAXTER BENTLEY LABORATORIES, INC. P.O. BOX 19522 Irvine,  CA  92713
ContactDonald A Raible
CorrespondentDonald A Raible
BAXTER BENTLEY LABORATORIES, INC. P.O. BOX 19522 Irvine,  CA  92713
Product CodeDWD  
CFR Regulation Number870.4430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-28
Decision Date1991-01-15

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