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FDA PMA

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

PMA Number: P130006 · 2026-05-26

ApplicantW. L. Gore & Associates, Inc.
Decision Date2026-05-26
PMA NumberP130006
Product CodePFV
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2026-05-26. The device is classified under product code PFV. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment?

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is W. L. Gore & Associates, Inc..

When did System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment receive FDA 510(k) clearance?

The clearance date for System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment can be found in the official FDA records.

Who is the listed applicant for System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment?

The FDA product code for System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment is PFV.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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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