FDA 510(k)

ViewFlex™ Eco Reprocessed ICE Catheter

K-Number: K230934 · 2023-05-03

Decision Date2023-05-03

Product CodeOWQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ViewFlex™ Eco Reprocessed ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2023-05-03 under 510(k) number K230934. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViewFlex™ Eco Reprocessed ICE Catheter?

ViewFlex™ Eco Reprocessed ICE Catheter is a medical device that received FDA 510(k) clearance on 2023-05-03. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K230934.

When did ViewFlex™ Eco Reprocessed ICE Catheter receive FDA 510(k) clearance?

ViewFlex™ Eco Reprocessed ICE Catheter received FDA 510(k) clearance on 2023-05-03, under 510(k) number K230934.

Who is the listed applicant for ViewFlex™ Eco Reprocessed ICE Catheter?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViewFlex™ Eco Reprocessed ICE Catheter?

The FDA product code for ViewFlex™ Eco Reprocessed ICE Catheter is OWQ.

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Related Devices (Code: OWQ)

K254149Reprocessed 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)Sterilmed, Inc.K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)Surgical Instrument Service and Savings, Inc.K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)Northeast Scientific, Inc.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.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.K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.