FDA 510(k) Application Details - K243493

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K243493
Device Name	Introducer, Catheter
Applicant	Abbott Medical 14901 DeVeau Place Minnetonka, MN 55345 US Other 510(k) Applications for this Company
Contact	Juan Ordonez Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2024
Decision Date	12/13/2024
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