DISPOSABLE SUMP SETS

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 Disposable Sump Sets.

Pre-market Notification Details

Device IDK801392
510k NumberK801392
Device Name:DISPOSABLE SUMP SETS
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant TEXAS MEDICAL PRODUCTS, 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 Received1980-06-13
Decision Date1980-06-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B0662010950006 K801392 000
B0662010890006 K801392 000
B0662010440006 K801392 000

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