FDA 510(k)

ViewFlex Xtra Reprocessed ICE Catheter

K-Number: K222217 · 2022-12-19

Decision Date2022-12-19

Product CodeOWQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ViewFlex Xtra 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 2022-12-19 under 510(k) number K222217. 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 Xtra Reprocessed ICE Catheter?

ViewFlex Xtra Reprocessed ICE Catheter is a medical device that received FDA 510(k) clearance on 2022-12-19. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K222217.

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

ViewFlex Xtra Reprocessed ICE Catheter received FDA 510(k) clearance on 2022-12-19, under 510(k) number K222217.

Who is the listed applicant for ViewFlex Xtra 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 Xtra Reprocessed ICE Catheter?

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06772493ViewFlex X ICE First-in-Human StudyRECRUITING

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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

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