OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
FDA 510(k) clearance K031282 · decided 2003-08-05
Clearance details
- K-number
- K031282
- Device name
- OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
- Applicant
- LeMaitre Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-22
- Decision date
- 2003-08-05
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| 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 |