FDA 510(k) Application Details - K213728

Device Classification Name	More FDA Info for this Device
510(K) Number	K213728
Device Name	Serranator PTA Serration Balloon Catheter
Applicant	Cagent Vascular, LLC 150 Strafford Avenue #315 Wayne, PA 19087 US Other 510(k) Applications for this Company
Contact	Carol Burns 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	11/26/2021
Decision Date	12/15/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review