ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
FDA 510(k) clearance K091987 · decided 2010-04-23
Clearance details
- K-number
- K091987
- Device name
- ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
- Applicant
- LeMaitre Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-02
- Decision date
- 2010-04-23
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size Models: 4007-02 Medium s recall (Z-0164-2011) | Lemaitre Vascular, Inc. | 2010-10-28 |
| LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large siz recall (Z-0165-2011) | Lemaitre Vascular, Inc. | 2010-10-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Artegraft Collagen Vascular Graft (N16837/S036) | LeMaitre Vascular, Inc. | 2025-06-11 |
| Artegraft Collagen Vascular Graft (N16837/S035) | LeMaitre Vascular, Inc. | 2024-12-18 |
| Artegraft Collagen Vascular Graft (N16837/S034) | LeMaitre Vascular, Inc. | 2024-10-17 |
| Artegraft Collagen Vascular Graft (N16837/S033) | LeMaitre Vascular, Inc. | 2024-05-02 |
| Artegraft Collagen Vascular Graft (N16837/S032) | LeMaitre Vascular, Inc. | 2023-09-19 |
| Artegraft Collagen Vascular Graft (N16837/S031) | LeMaitre Vascular, Inc. | 2023-06-29 |
| Artegraft Collagen Vascular Graft (N16837/S030) | LeMaitre Vascular, Inc. | 2023-04-25 |
| Artegraft Collagen Vascular Graft (N16837/S029) | LeMaitre Vascular, Inc. | 2023-01-25 |