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FDA 510(k)

exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft

K-Number: K202471 · 2020-12-11

ApplicantPeca Labs
Decision Date2020-12-11
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft is a medical device manufactured by Peca Labs. It received FDA 510(k) clearance on 2020-12-11 under approval number K202471. 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 ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft?

exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft is a medical device that received FDA 510(k) clearance on 2020-12-11. It is manufactured by Peca Labs. The 510(k) number is K202471.

When was exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft approved by the FDA?

exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft received FDA 510(k) clearance on 2020-12-11, under approval number K202471.

What company makes exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft?

exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft is manufactured by Peca Labs.

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

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

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT01619917 The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars RECRUITING NCT07557862 Multi-Site STARgraft (10401) Trial NOT_YET_RECRUITING NCT07555717 STARgraft (10401) Pilot RECRUITING NCT05729620 Evaluation of STARgraft-3 for Hemodialysis ACTIVE_NOT_RECRUITING NCT07216885 Solv Multi-Pass Hemodialysis System In-Center Clinical Study RECRUITING

Other Devices by Peca Labs

K180957exGraft, exGraft Carbon ePTFE Vascular Grafts K183613exGraft, exGraft Carbon K221628exGraft, exGraft Carbon

Related Devices (Code: DSY)

K153523FUSION Vascular GraftMaquet Cardiovascular, LLC K172637HeRO GraftMerit Medical Systems, Inc. K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd. K162794Gelweave Vascular GraftsVascutek, Ltd. K180957exGraft, exGraft Carbon ePTFE Vascular GraftsPeca Labs K183613exGraft, exGraft CarbonPeca Labs

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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