TROCAR CATHETER/THORACIC CATHETER

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

PORTEX, INC.

The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Trocar Catheter/thoracic Catheter.

Pre-market Notification Details

Device IDK792202
510k NumberK792202
Device Name:TROCAR CATHETER/THORACIC CATHETER
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant PORTEX, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-02
Decision Date1979-11-20

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