Atlas FDA

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

FDA 510(k) clearance K232130 · decided 2023-12-15

Clearance details

K-number
K232130
Device name
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
Applicant
Surgical Instrument Services and Savings, Inc.
Decision
Substantially Equivalent
Date received
2023-07-17
Decision date
2023-12-15
Days to decision
151 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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Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) (K254149)Sterilmed, Inc.2026-06-29
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Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) (K243101)Surgical Instrument Service and Savings, Inc.2025-03-10
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) (K234064)Surgical Instrument Service and Savings, Inc.2024-09-10
Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter (K232584)Vein 360, LLC2023-10-24
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ViewFlex™ Eco Reprocessed ICE Catheter (K230934)ABBOTT MEDICAL2023-05-03
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (K223026)Northeast Scientific, Inc.2023-02-03

Recalls involving this device

RecordFirmDate
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 9 recall (Z-1323-2026)Medline Industries, LP2026-02-06
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and oth recall (Z-2613-2025)Medline Industries, LP2025-09-26