FDA 510(k) Application Details - K232321

Device Classification Name	Catheter, Steerable   More FDA Info for this Device
510(K) Number	K232321
Device Name	Catheter, Steerable
Applicant	Medtronic Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	Kripa Pandya 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	08/03/2023
Decision Date	10/31/2023
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