Atlas FDA

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

FDA 510(k) clearance K232584 · decided 2023-10-24

Clearance details

K-number
K232584
Device name
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
Applicant
Vein 360, LLC
Decision
Substantially Equivalent
Date received
2023-08-25
Decision date
2023-10-24
Days to decision
60 days
Clearance type
Traditional
Product code
OWQ
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Blue Ash, OH, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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
Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (K250545)Surgical Instrument Service and Savings, Inc.2025-06-05
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (K250592)Northeast Scientific, Inc.2025-05-12
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
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter (K232130)Surgical Instrument Services and Savings, Inc.2023-12-15
Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter (K230928)Vein 360, LLC2023-08-25
Reprocessed ViewFlex Xtra ICE Catheter (D087031) (K231621)Stryker Sustainability Solutions2023-07-25
ViewFlex™ Eco Reprocessed ICE Catheter (K231588)ABBOTT MEDICAL2023-06-30
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (K230584)Vein 360, LLC2023-06-06
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

No recalls on record reference this clearance.