SCIMED R30 SILICONE ASSIST RESERVOIR

Reservoir, Blood, 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 R30 Silicone Assist Reservoir.

Pre-market Notification Details

Device IDK882720
510k NumberK882720
Device Name:SCIMED R30 SILICONE ASSIST RESERVOIR
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis,  MN  55441
ContactSwanson Lano
CorrespondentSwanson Lano
SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis,  MN  55441
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-01
Decision Date1988-09-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30613994010446 K882720 000
30613994010439 K882720 000

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