FDA 510(k) Application Details - K214107

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K214107
Device Name	Catheter, Percutaneous
Applicant	Transit Scientific, LLC 2757 South 300 West, Suite E Salt Lake City, UT 84115 US Other 510(k) Applications for this Company
Contact	Jennifer Arnold Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2021
Decision Date	04/11/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review