Gelweave Vascular Prostheses— 510(k) K241550
Substantially EquivalentVascutek, Ltd.
FDA 510(k) clearance K241550 for Gelweave Vascular Prostheses, Substantially Equivalent on 2025-02-27. 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
- Traditional
- Location
- Inchinnan, GB
Recent devices under product code DSY
view allMore clearances from Vascutek, Ltd.
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 →
Recalls naming K241550
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 K241550.
Data sourced from openFDA. This site is unofficial and independent of the FDA.