PRE-BYPASS FILTER

Filter, Prebypass, 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 Pre-bypass Filter.

Pre-market Notification Details

Device IDK810395
510k NumberK810395
Device Name:PRE-BYPASS FILTER
ClassificationFilter, Prebypass, Cardiopulmonary Bypass
Applicant TEXAS MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKRJ  
CFR Regulation Number870.4280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-02-18
Decision Date1981-03-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.