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FDA 510(k)

Fusion Bioline Vascular Graft

K-Number: K252445 · 2026-04-27

ApplicantMaquet Cardiovascular, LLC
Decision Date2026-04-27
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fusion Bioline Vascular Graft is a medical device manufactured by Maquet Cardiovascular, LLC. It received FDA 510(k) clearance on 2026-04-27 under approval number K252445. 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 Fusion Bioline Vascular Graft?

Fusion Bioline Vascular Graft is a medical device that received FDA 510(k) clearance on 2026-04-27. It is manufactured by Maquet Cardiovascular, LLC. The 510(k) number is K252445.

When was Fusion Bioline Vascular Graft approved by the FDA?

Fusion Bioline Vascular Graft received FDA 510(k) clearance on 2026-04-27, under approval number K252445.

What company makes Fusion Bioline Vascular Graft?

Fusion Bioline Vascular Graft is manufactured by Maquet Cardiovascular, LLC.

What is the FDA product code for Fusion Bioline Vascular Graft?

The FDA product code for Fusion Bioline Vascular Graft is DSY.

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Other Devices by Maquet Cardiovascular, LLC

K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting System K153523FUSION Vascular Graft K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord K1919307 mm Extended Length Endoscope K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)

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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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