XO Cross Support Catheter

Catheter, Percutaneous

Transit Scientific

The following data is part of a premarket notification filed by Transit Scientific with the FDA for Xo Cross Support Catheter.

Pre-market Notification Details

Device IDK193420
510k NumberK193420
Device Name:XO Cross Support Catheter
ClassificationCatheter, Percutaneous
Applicant Transit Scientific 2757 South 300 West, Suite E Salt Lake City,  UT  84115
ContactJenifer Arnold
CorrespondentSpencer Walker
University Of Utah 10 North 1900 East, EHSL Rm. 22B Salt Lake City,  UT  84112
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-09
Decision Date2020-05-06

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