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FDA 510(k)

ViewFlex Xtra Reprocessed ICE Catheter

K-Number: K222217 · 2022-12-19

ApplicantABBOTT MEDICAL
Decision Date2022-12-19
Product CodeOWQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ViewFlex Xtra Reprocessed ICE Catheter is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2022-12-19 under approval 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. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K222217.

When was ViewFlex Xtra Reprocessed ICE Catheter approved by the FDA?

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

What company makes ViewFlex Xtra Reprocessed ICE Catheter?

ViewFlex Xtra Reprocessed ICE Catheter is manufactured by ABBOTT MEDICAL.

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

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

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Related Devices (Code: OWQ)

K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound CathetersSterilmed, Inc. K153090Reprocessed Diagnostic Ultrasound CatheterInnovative Health, LLC K163560Reprocessed AcuNav Diagnostic Ultrasound CatheterInnovative Health, LLC K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC K173262Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC K190478Reprocessed ViewFlex™ Xtra ICE CatheterSterilmed, 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.

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