Atlas FDA

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

FDA 510(k) clearance K250545 · decided 2025-06-05

Clearance details

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.
Decision
Substantially Equivalent
Date received
2025-02-25
Decision date
2025-06-05
Days to decision
100 days
Clearance type
Traditional
Product code
OWQ
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Redmond, OR, US
Third-party review
No
Expedited review
No

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Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter (K232130)Surgical Instrument Services and Savings, Inc.2023-12-15
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Recalls involving this device

RecordFirmDate
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webst recall (Z-1324-2026)Medline Industries, LP2026-02-06