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FDA 510(k)

Reprocessed ViewFlex™ Xtra ICE Catheter

K-Number: K190478 · 2019-11-14

ApplicantSterilmed, Inc.
Decision Date2019-11-14
Product CodeOWQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed ViewFlex™ Xtra ICE Catheter is a medical device manufactured by Sterilmed, Inc.. It received FDA 510(k) clearance on 2019-11-14 under approval number K190478. 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 Reprocessed ViewFlex™ Xtra ICE Catheter?

Reprocessed ViewFlex™ Xtra ICE Catheter is a medical device that received FDA 510(k) clearance on 2019-11-14. It is manufactured by Sterilmed, Inc.. The 510(k) number is K190478.

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

Reprocessed ViewFlex™ Xtra ICE Catheter received FDA 510(k) clearance on 2019-11-14, under approval number K190478.

What company makes Reprocessed ViewFlex™ Xtra ICE Catheter?

Reprocessed ViewFlex™ Xtra ICE Catheter is manufactured by Sterilmed, Inc..

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

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

Other Devices by Sterilmed, Inc.

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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 K182238Reprocessed ViewFlex Xtra ICE CatheterStryker Sustainability Solutions

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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