AORTIC AND FEMORAL PERFUSION CANNULAE

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

TEXAS MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Aortic And Femoral Perfusion Cannulae.

Pre-market Notification Details

Device IDK801398
510k NumberK801398
Device Name:AORTIC AND FEMORAL PERFUSION CANNULAE
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant TEXAS MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-06-13
Decision Date1980-06-30

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