HEPARIN-COATED BALLOON THERMODILUT

Catheter, Flow Directed

CRITIKON COMPANY,LLC

The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Heparin-coated Balloon Thermodilut.

Pre-market Notification Details

Device IDK833572
510k NumberK833572
Device Name:HEPARIN-COATED BALLOON THERMODILUT
ClassificationCatheter, Flow Directed
Applicant CRITIKON COMPANY,LLC 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDYG  
CFR Regulation Number870.1240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-10-12
Decision Date1984-01-30

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