PhasTIPP
FDA 510(k) clearance K212894 · decided 2022-03-31
Clearance details
- K-number
- K212894
- Device name
- PhasTIPP
- Applicant
- LeMaitre Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-10
- Decision date
- 2022-03-31
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- DWQ
- Device class
- 2
- Regulation number
- 870.4885
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- 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.
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 (K041453) | Smith & Nephew, Inc. | 2004-07-22 |
| TRIVEX SYSTEM (K032387) | Smith & Nephew, Inc. | 2003-10-29 |
| URESIL VALVE CUTTER (K905528) | Uresil Corp. | 1991-04-18 |
| PILLING BRUSH VALVULOTOME (K904507) | Pilling Co. | 1991-03-01 |
| INSITUCAT VALVE STRIPPER (K885046) | Aesculap Instruments Corp. | 1990-02-28 |
| HALL VEIN STRIPPER (K872157) | Solco Basle, Inc. | 1987-07-07 |
| VEIN-TRAP TM (K811910) | Atrium Medical Corp. | 1981-07-20 |
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 |