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FDA 510(k)

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts

K-Number: K233783 · 2024-01-17

ApplicantPeca Labs, Inc.
Decision Date2024-01-17
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts is a medical device manufactured by Peca Labs, Inc.. It received FDA 510(k) clearance on 2024-01-17 under approval number K233783. 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 Grafts, exGraft Carbon ePTFE Vascular Grafts?

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts is a medical device that received FDA 510(k) clearance on 2024-01-17. It is manufactured by Peca Labs, Inc.. The 510(k) number is K233783.

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

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts received FDA 510(k) clearance on 2024-01-17, under approval number K233783.

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

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts is manufactured by Peca Labs, Inc..

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

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

Related Clinical Trials

NCT07557862 Multi-Site STARgraft (10401) Trial NOT_YET_RECRUITING NCT07555717 STARgraft (10401) Pilot RECRUITING NCT05729620 Evaluation of STARgraft-3 for Hemodialysis ACTIVE_NOT_RECRUITING

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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