FDA 510(k) Application Details - K231311

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K231311
Device Name	Catheter, Percutaneous
Applicant	Abbott Medical 15900 Valley View Court Sylmar, CA 91342 US Other 510(k) Applications for this Company
Contact	Mary Adams 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	05/05/2023
Decision Date	06/02/2023
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