FDA 510(k) Application Details - K240997

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K240997
Device Name	Wire, Guide, Catheter
Applicant	Abbott Medical 3200 Lakeside Drive Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Angeline Chooi Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2024
Decision Date	11/06/2024
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