FDA 510(k) Application Details - K243224

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K243224
Device Name	Catheter, Percutaneous
Applicant	Abbott Medical 177 County Road B East St. Paul, MN 55117 US Other 510(k) Applications for this Company
Contact	Vidya Thyagarajan Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2024
Decision Date	12/31/2024
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