FDA 510(k) Application Details - K250545

Device Classification Name	More FDA Info for this Device
510(K) Number	K250545
Device Name	Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
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	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	02/25/2025
Decision Date	06/05/2025
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