FDA 510(k) Application Details - K221067

Device Classification Name	Catheter, Recording, Electrode, Reprocessed   More FDA Info for this Device
510(K) Number	K221067
Device Name	Catheter, Recording, Electrode, Reprocessed
Applicant	Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 US Other 510(k) Applications for this Company
Contact	Stephanie Boyle Mays Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	NLH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2022
Decision Date	05/31/2023
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