BARD 3DMAX MESH— 510(k) K081010
Substantially EquivalentDavol Inc., Sub. C. R. Bard, Inc.
FDA 510(k) clearance K081010 for BARD 3DMAX MESH, Substantially Equivalent on 2008-10-07. Applicant: Davol Inc., Sub. C. R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- 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
- Canston, RI, US
Recent devices under product code FTL
view allMore clearances from Davol Inc., Sub. C. R. Bard, Inc.
view all- K101851 — VENTRALIGHT ST MESH
- K092032 — BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
- K061754 — BARD COMPOSITE L/P MESH
- K061314 — BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
- K051848 — SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079
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.