FDA 510(k)

exGraft, exGraft Carbon

K-Number: K221628 · 2022-08-04

Decision Date2022-08-04

Product CodeDSY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

exGraft, exGraft Carbon is a medical device manufactured by Peca Labs. It received FDA 510(k) clearance on 2022-08-04 under approval number K221628. 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?

exGraft, exGraft Carbon is a medical device that received FDA 510(k) clearance on 2022-08-04. It is manufactured by Peca Labs. The 510(k) number is K221628.

When was exGraft, exGraft Carbon approved by the FDA?

exGraft, exGraft Carbon received FDA 510(k) clearance on 2022-08-04, under approval number K221628.

What company makes exGraft, exGraft Carbon?

exGraft, exGraft Carbon is manufactured by Peca Labs.

What is the FDA product code for exGraft, exGraft Carbon?

The FDA product code for exGraft, exGraft Carbon is DSY.

Other Devices by Peca Labs

K180957exGraft, exGraft Carbon ePTFE Vascular Grafts K183613exGraft, exGraft Carbon K202471exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.