FDA.reportPublic FDA data

510(k) K250592

Device
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
Applicant
Northeast Scientific, Inc.
510(k) number
K250592
Product code
OWQ
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-12
Date received
2025-02-27
Regulation
870.1200
Classification name
Reprocessed Intravascular Ultrasound Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Matthew Farley
Address
2142 Thomaston Ave. Waterbury CT US 06704 06704

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OWQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)Surgical Instrument Service and Savings, Inc.2025-06-05
K243101Medline 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)Surgical Instrument Service and Savings, Inc.2025-03-10
K234064Medline 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)Surgical Instrument Service and Savings, Inc.2024-09-10
K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, Inc.2023-12-15
K232584Vein360 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 CatheterVein 360, LLC2023-10-24
K230928Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterVein 360, LLC2023-08-25
K231621Reprocessed ViewFlex Xtra ICE Catheter (D087031)Stryker Sustainability Solutions2023-07-25
K231588ViewFlex™ Eco Reprocessed ICE CatheterABBOTT MEDICAL2023-06-30
K230584Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC2023-06-06
K230934ViewFlex™ Eco Reprocessed ICE CatheterABBOTT MEDICAL2023-05-03
K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNortheast Scientific, Inc.2023-02-03
K222217ViewFlex Xtra Reprocessed ICE CatheterABBOTT MEDICAL2022-12-19
K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterInnovative Health, LLC2022-05-25
K202042Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC2020-11-20
K190478Reprocessed ViewFlex™ Xtra ICE CatheterSterilmed, Inc.2019-11-14