Fusion Bioline Vascular Graft— 510(k) K252445
Substantially EquivalentMaquet Cardiovascular, LLC
FDA 510(k) clearance K252445 for Fusion Bioline Vascular Graft, Substantially Equivalent on 2026-04-27. Applicant: Maquet Cardiovascular, LLC. Device class: 2.
Summary
Maquet Cardiovascular's Fusion Bioline Vascular Graft is filed under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter).
Class II, 21 CFR 870.3450. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Maquet Cardiovascular filed from Wayne, New Jersey. The record shows 266 calendar days from receipt to decision (August 4, 2025 to April 27, 2026).
Clearance details
- Applicant
- Maquet Cardiovascular, LLC
- Product code
- Product code DSY
- Device class
- Class 2
- Regulation
- 21 CFR 870.3450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wayne, NJ, US
Recent devices under product code DSY
view allMore clearances from Maquet Cardiovascular, LLC
view all- K251238 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000) +2 more
- K243918 — Vasoview Hemopro 3 Power Supply
- K233879 — Vasoview 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)
- K191930 — 7 mm Extended Length Endoscope
- K191947 — VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord
Adverse events under product code DSY
product code DSY- Death
- 29
- Injury
- 694
- Total
- 723
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.