FDA 510(k) Application Details - K232130

Device Classification Name	More FDA Info for this Device
510(K) Number	K232130
Device Name	Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
Applicant	Surgical Instrument Services 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	More FDA Info for this Regulation Number
Classification Product Code	OWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2023
Decision Date	12/15/2023
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