7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH

Catheter, Flow Directed

WATERS ASSOC., INC.

The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for 7french Flow Directed Triple Lumen Cath.

Pre-market Notification Details

Device IDK802481
510k NumberK802481
Device Name:7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH
ClassificationCatheter, Flow Directed
Applicant WATERS ASSOC., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDYG  
CFR Regulation Number870.1240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-07
Decision Date1980-10-31

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