MODIFIED CORONARY CARDIOPLEGIA ADAPTOR

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 Modified Coronary Cardioplegia Adaptor.

Pre-market Notification Details

Device IDK854640
510k NumberK854640
Device Name:MODIFIED CORONARY CARDIOPLEGIA ADAPTOR
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
ContactDavid Thomas
CorrespondentDavid Thomas
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 Received1985-11-19
Decision Date1986-02-10

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