FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
FDA 510(k) clearance K071367 · decided 2007-08-29
Clearance details
- K-number
- K071367
- Device name
- FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
- Applicant
- LeMaitre Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-16
- Decision date
- 2007-08-29
- Days to decision
- 105 days
- Clearance type
- Special
- Product code
- MJN
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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 |