C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic— 510(k) K151386
Substantially EquivalentAtrium Medical Corporation
FDA 510(k) clearance K151386 for C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic, Substantially Equivalent on 2015-10-22. Applicant: Atrium Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Atrium Medical Corporation
- Product code
- Code FTL
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hudson, NH, US
Recent devices under product code FTL
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view all- K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft
- K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
- K151437 — ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
- K130142 — FLIXENE IFG VASCULAR GRAFT
- K110110 — ATRIUM CENTRILFX MESH
Adverse events under product code FTL
product code FTL- Death
- 317
- Injury
- 66,072
- Malfunction
- 1,273
- Other
- 3
- Total
- 67,665
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.