LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
FDA 510(k) clearance K023688 · decided 2003-01-30
Clearance details
- K-number
- K023688
- Device name
- LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
- Applicant
- LeMaitre Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-01
- Decision date
- 2003-01-30
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GAF
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch LeMaitre Vascular
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SNAP RECIPROCATING SAW (K935357) | Surgiquip, Inc. | 1994-01-28 |
| ABDOMINAL SPATULA (K890374) | Kinetic Medical Products | 1989-02-03 |
| PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE (K882793) | Pmt Corp. | 1988-07-18 |
| CEMENT-PICK (K822108) | Bio-Blitz, Inc. | 1982-08-11 |
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 |