ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

SHERWOOD MEDICAL CO.

The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Griffith Tdmac Heparinized Veno-venous Shun.

Pre-market Notification Details

Device IDK850917
510k NumberK850917
Device Name:ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis,  MO  63103 -1625
ContactFrank J Fucile
CorrespondentFrank J Fucile
SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis,  MO  63103 -1625
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-05
Decision Date1985-05-21

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