STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN

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 Stockert-shiley Venous Catheter & Aortic Arch Cann.

Pre-market Notification Details

Device IDK844137
510k NumberK844137
Device Name:STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
ContactRobert Curtis
CorrespondentRobert Curtis
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 Received1984-10-23
Decision Date1984-12-27

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