STOCKERT-SHILEY INTRACARDIAC SUCKERS

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 Intracardiac Suckers.

Pre-market Notification Details

Device IDK844139
510k NumberK844139
Device Name:STOCKERT-SHILEY INTRACARDIAC SUCKERS
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant SHILEY, INC. 17600 GILLETTE AVENUE
ContactRobert Curtis
CorrespondentRobert Curtis
SHILEY, INC. 17600 GILLETTE AVENUE
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-23
Decision Date1984-12-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.