CARDIAC INSULATION PAD

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 Cardiac Insulation Pad.

Pre-market Notification Details

Device IDK781990
510k NumberK781990
Device Name:CARDIAC INSULATION PAD
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant SHILEY, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-11-27
Decision Date1978-12-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10803622131896 K781990 000
10803622131889 K781990 000

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