TXM Support Catheter

Catheter, Percutaneous

Texas Medical Technologies, Inc.

The following data is part of a premarket notification filed by Texas Medical Technologies, Inc. with the FDA for Txm Support Catheter.

Pre-market Notification Details

Device IDK170914
510k NumberK170914
Device Name:TXM Support Catheter
ClassificationCatheter, Percutaneous
Applicant Texas Medical Technologies, Inc. 2118 Wilshire Blvd. #682 Santa Monica,  CA  90403
ContactEd Anderson
CorrespondentE.j. Smith
Smith Associates 1468 Harwell Avenue Crofton,  MD  21114
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-28
Decision Date2017-11-21
Summary:summary

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