FDA 510(k) Application Details - K242419

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K242419
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	Creagh Medical Ltd. dba Surmodics, Inc. IDA Business Park, Ballinasloe Co. Galway Balinasloe H53 K8P4 IE Other 510(k) Applications for this Company
Contact	Brendan McCormack 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	08/15/2024
Decision Date	11/15/2024
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