SCIMED ECMOTHERM(TM) HEAT EXCHANGER

Heat-exchanger, Cardiopulmonary Bypass

SCIMED LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Ecmotherm(tm) Heat Exchanger.

Pre-market Notification Details

Device IDK884560
510k NumberK884560
Device Name:SCIMED ECMOTHERM(TM) HEAT EXCHANGER
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant SCIMED LIFE SYSTEMS, INC. 2905 NORTHWEST BLVD. SUITE 60 Plymouth,  MN  55441
ContactSwanson Lano
CorrespondentSwanson Lano
SCIMED LIFE SYSTEMS, INC. 2905 NORTHWEST BLVD. SUITE 60 Plymouth,  MN  55441
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-31
Decision Date1989-04-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994009647 K884560 000
00613994008701 K884560 000
30613994009648 K884560 000
30613994008702 K884560 000

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