510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250545Substantially Equivalent

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

Medline ReNewal, Redmond OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250545 is the FDA 510(k) clearance record for Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG), a class II device, cleared for Surgical Instrument Service and Savings, Inc. on under FDA product code OWQ (Reprocessed Intravascular Ultrasound Catheter). FDA's definition for product code OWQ reads: "For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology". FDA records list 24 510(k) clearances for Medline ReNewal, from to . As of , FDA records show one recall naming K250545.

Clearance record

Decision date
Received
(100 days to decision)
Product code
OWQ Reprocessed Intravascular Ultrasound Catheter
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Surgical Instrument Service and Savings, Inc. (Dba Medline Renewal), Redmond OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWQ

Trailing 12 months
1 clearance under product code OWQ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OWQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260