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FDA 510(k)

Reprocessed Agilis NxT Steerable Introducer

K-Number: K250305 · 2026-01-07

ApplicantInnovative Health
Decision Date2026-01-07
Product CodePNE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Agilis NxT Steerable Introducer is a medical device manufactured by Innovative Health. It received FDA 510(k) clearance on 2026-01-07 under approval number K250305. The device is classified under product code PNE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Agilis NxT Steerable Introducer?

Reprocessed Agilis NxT Steerable Introducer is a medical device that received FDA 510(k) clearance on 2026-01-07. It is manufactured by Innovative Health. The 510(k) number is K250305.

When was Reprocessed Agilis NxT Steerable Introducer approved by the FDA?

Reprocessed Agilis NxT Steerable Introducer received FDA 510(k) clearance on 2026-01-07, under approval number K250305.

What company makes Reprocessed Agilis NxT Steerable Introducer?

Reprocessed Agilis NxT Steerable Introducer is manufactured by Innovative Health.

What is the FDA product code for Reprocessed Agilis NxT Steerable Introducer?

The FDA product code for Reprocessed Agilis NxT Steerable Introducer is PNE.

Related Clinical Trials

NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING NCT06223789 VOLT-AF IDE Clinical Study COMPLETED

Other Devices by Innovative Health

K233825Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter

Related Devices (Code: PNE)

K152090Reprocessed Steerable IntroducerSterilmed, Inc. K170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC K230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLC K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service 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.

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