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.
Clearance details
- Applicant
- Maquet Cardiovascular, LLC
- Product code
- 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.