FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT— 510(k) K131778
Substantially EquivalentMaquet Cardiovascular, LLC
FDA 510(k) clearance K131778 for FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT, Substantially Equivalent on 2013-11-14. 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
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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 →
Recalls naming K131778
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131778.
Data sourced from openFDA. This site is unofficial and independent of the FDA.