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510(k) K250305

Device
Reprocessed Agilis NxT Steerable Introducer
Applicant
Innovative Health
510(k) number
K250305
Product code
PNE
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-07
Date received
2025-02-03
Regulation
870.1340
Classification name
Reprocessed Catheter Introducer
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Rick Ferreira
Address
1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.2025-12-19
K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLC2024-04-04
K230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC2023-08-07
K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC2022-03-10
K170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC2017-06-02
K152090Reprocessed Steerable IntroducerSterilmed, Inc.2016-03-23