FDA 510(k) Application Details - K221397

Device Classification Name	Catheter, Steerable   More FDA Info for this Device
510(K) Number	K221397
Device Name	Catheter, Steerable
Applicant	Abbott Medical 177 Country Road B East Saint Paul, MN 55117 US Other 510(k) Applications for this Company
Contact	Cynthia Aguirre Other 510(k) Applications for this Contact
Regulation Number	870.1280   More FDA Info for this Regulation Number
Classification Product Code	DRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2022
Decision Date	09/28/2022
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