POLYURETHANE THERMAL DILUTION CATHET

Catheter, Flow Directed

WATERS INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Waters Instruments, Inc. with the FDA for Polyurethane Thermal Dilution Cathet.

Pre-market Notification Details

Device IDK841876
510k NumberK841876
Device Name:POLYURETHANE THERMAL DILUTION CATHET
ClassificationCatheter, Flow Directed
Applicant WATERS INSTRUMENTS, 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 Received1984-05-07
Decision Date1984-07-13

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