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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 the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health. It received FDA 510(k) clearance on 2026-01-07 under 510(k) 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. The listed applicant is Innovative Health. The 510(k) number is K250305.

When did Reprocessed Agilis NxT Steerable Introducer receive FDA 510(k) clearance?

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

Who is the listed applicant for Reprocessed Agilis NxT Steerable Introducer?

The FDA 510(k) record lists Innovative Health as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT06106594VOLT CE Mark StudyACTIVE_NOT_RECRUITINGNCT06223789VOLT-AF IDE Clinical StudyCOMPLETED

Other records listing Innovative Health as applicant

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.

K231015Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic CathetersK233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterK232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathK230376Reprocessed Agilis NxT Steerable IntroducerK213584Reprocessed NRG Transseptal NeedleK221854Reprocesses Umbilical Cable

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Related Devices (Code: PNE)

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.

K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLCK230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLCK212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLCK170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLCK152090Reprocessed Steerable IntroducerSterilmed, 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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