FDA 510(k) Application Details - K192399

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K192399
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	Infinity Angioplasty Balloon Company, LLC 6865 N. Reynolds Rd Suite 200 Toledo, OH 43615 US Other 510(k) Applications for this Company
Contact	Tiffini Wittwer Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	LIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2019
Decision Date	05/20/2020
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