ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug— 510(k) K151437
Substantially EquivalentAtrium Medical Corporation
FDA 510(k) clearance K151437 for ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug, Substantially Equivalent on 2015-08-27. 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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- K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
- K151386 — C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
- 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 →
Recalls naming K151437
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 K151437.
Data sourced from openFDA. This site is unofficial and independent of the FDA.