SILICONE FLOW-DIRECTED THERMODILUTION CATHETER

Catheter, Flow Directed

CATHLAB CORP.

The following data is part of a premarket notification filed by Cathlab Corp. with the FDA for Silicone Flow-directed Thermodilution Catheter.

Pre-market Notification Details

Device IDK893435
510k NumberK893435
Device Name:SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
ClassificationCatheter, Flow Directed
Applicant CATHLAB CORP. 2695 DOW AVE. Tustin,  CA  92680
ContactDaniel R Lucas
CorrespondentDaniel R Lucas
CATHLAB CORP. 2695 DOW AVE. Tustin,  CA  92680
Product CodeDYG  
CFR Regulation Number870.1240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-02
Decision Date1989-09-26

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