STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE

Pump, Blood, Cardiopulmonary Bypass, Roller Type

SHILEY, INC.

The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Stockert-shiley Multiflow Roller Pump Module.

Pre-market Notification Details

Device IDK861714
510k NumberK861714
Device Name:STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
ClassificationPump, Blood, Cardiopulmonary Bypass, Roller Type
Applicant SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
ContactMorton Barak
CorrespondentMorton Barak
SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
Product CodeDWB  
CFR Regulation Number870.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-05
Decision Date1986-07-16

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