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FDA 510(k)

exGraft, exGraft Carbon ePTFE Vascular Grafts

K-Number: K180957 · 2018-08-21

ApplicantPeca Labs
Decision Date2018-08-21
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

exGraft, exGraft Carbon ePTFE Vascular Grafts is the device name listed in this FDA 510(k) record. The listed applicant is Peca Labs. It received FDA 510(k) clearance on 2018-08-21 under 510(k) number K180957. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the exGraft, exGraft Carbon ePTFE Vascular Grafts?

exGraft, exGraft Carbon ePTFE Vascular Grafts is a medical device that received FDA 510(k) clearance on 2018-08-21. The listed applicant is Peca Labs. The 510(k) number is K180957.

When did exGraft, exGraft Carbon ePTFE Vascular Grafts receive FDA 510(k) clearance?

exGraft, exGraft Carbon ePTFE Vascular Grafts received FDA 510(k) clearance on 2018-08-21, under 510(k) number K180957.

Who is the listed applicant for exGraft, exGraft Carbon ePTFE Vascular Grafts?

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

What is the FDA product code for exGraft, exGraft Carbon ePTFE Vascular Grafts?

The FDA product code for exGraft, exGraft Carbon ePTFE Vascular Grafts is DSY.

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.

NCT05729620Evaluation of STARgraft-3 for HemodialysisACTIVE_NOT_RECRUITING

Other records listing Peca Labs 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.

K233783exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsK221628exGraft, exGraft CarbonK202471exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular GraftK183613exGraft, exGraft Carbon

Related Devices (Code: DSY)

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.

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, 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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