DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

SHILEY, INC.

The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Dideco-shiley Autotransfusion Accessories.

Pre-market Notification Details

Device IDK872159
510k NumberK872159
Device Name:DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
ContactGanz Pobuda
CorrespondentGanz Pobuda
SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-04
Decision Date1987-08-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38033178105478 K872159 000

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