FDA 510(k) Application Details - K211989

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K211989
Device Name	Introducer, Catheter
Applicant	Abbott Medical 15900 Valley View Court Sylmar, CA 91342 US Other 510(k) Applications for this Company
Contact	Bijal Jain 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	06/28/2021
Decision Date	07/27/2021
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