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FDA 510(k)

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

K-Number: K232130 · 2023-12-15

ApplicantSurgical Instrument Services and Savings, Inc.
Decision Date2023-12-15
Product CodeOWQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is a medical device manufactured by Surgical Instrument Services and Savings, Inc.. It received FDA 510(k) clearance on 2023-12-15 under approval number K232130. 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 Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter?

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Surgical Instrument Services and Savings, Inc.. The 510(k) number is K232130.

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

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter received FDA 510(k) clearance on 2023-12-15, under approval number K232130.

What company makes Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter?

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is manufactured by Surgical Instrument Services and Savings, Inc..

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

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

Other Devices by Surgical Instrument Services and Savings, Inc.

K152313Medline ReNewal Reprocessed Endopath Endoscopic Instruments K162751Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider

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

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

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