FDA 510(k) Application Details - K230191

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K230191
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	Creagh Medical Ltd IDA Business Park Ballinasloe H53 K8P4 IE Other 510(k) Applications for this Company
Contact	Peter Bather 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	01/24/2023
Decision Date	03/22/2023
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