FDA.report

510(k) K231588

Device
ViewFlex? Eco Reprocessed ICE Catheter
Applicant
ABBOTT MEDICAL
510(k) number
K231588
Product code
OWQ
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-30
Date received
2023-06-01
Regulation
870.1200
Classification name
Reprocessed Intravascular Ultrasound Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Quynh Phuong Le
Address
14901 Deveau Pl. Minnetonka MN US 55345 55345

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OWQ

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
K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)Northeast Scientific, Inc.2025-05-12
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
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