VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS— 510(k) K060142
Substantially EquivalentVascutek, Ltd.
FDA 510(k) clearance K060142 for VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS, Substantially Equivalent on 2006-02-07. Applicant: Vascutek, Ltd.. Device class: 2.
Clearance details
- Applicant
- Vascutek, Ltd.
- 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
- Special
- Location
- Renfrewshire, Glasgow, GB
Recent devices under product code DSY
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view all- K202703 — Vascutek Gelsoft Plus ERS Vascular Graft
- K200955 — Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
- K162803 — Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
- K162794 — Gelweave Vascular Grafts
- K093817 — GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
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.