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 a medical device manufactured by Peca Labs. It received FDA 510(k) clearance on 2018-08-21 under approval 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. It is manufactured by Peca Labs. The 510(k) number is K180957.
When was exGraft, exGraft Carbon ePTFE Vascular Grafts approved by the FDA?
exGraft, exGraft Carbon ePTFE Vascular Grafts received FDA 510(k) clearance on 2018-08-21, under approval number K180957.
What company makes exGraft, exGraft Carbon ePTFE Vascular Grafts?
exGraft, exGraft Carbon ePTFE Vascular Grafts is manufactured by Peca Labs.
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.
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K162794Gelweave Vascular GraftsVascutek, Ltd.
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K202471exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular GraftPeca 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.