FDA 510(k) Application Details - K193495

Device Classification Name	More FDA Info for this Device
510(K) Number	K193495
Device Name	XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
Applicant	Transit Scientific 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	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2019
Decision Date	05/29/2020
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