510(k) K032387
- Device
- TRIVEX SYSTEM
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K032387
- Product code
- DWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-29
- Date received
- 2003-08-04
- Regulation
- 870.4885
- Classification name
- Stripper, Vein, External
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN PROVENCHER
- Address
- 150 Minuteman Rd. Andover MA US 01810 01810
FDA Registration Numbers#
- 3010041511
- 9710524
- 1319639
- 3011137372
- 8040233
- 2523676
- 1220948
Source Documents#
Other 510(k) Records For Product Code DWQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212894 | PhasTIPP | LeMaitre Vascular, Inc. | 2022-03-31 |
| K041453 | SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 | Smith & Nephew, Inc. | 2004-07-22 |
| K905528 | URESIL VALVE CUTTER | Uresil Corp. | 1991-04-18 |
| K904507 | PILLING BRUSH VALVULOTOME | Pilling Co. | 1991-03-01 |
| K885046 | INSITUCAT VALVE STRIPPER | Aesculap Instruments Corp. | 1990-02-28 |
| K872157 | HALL VEIN STRIPPER | Solco Basle, Inc. | 1987-07-07 |
| K811910 | VEIN-TRAP TM | Atrium Medical Corp. | 1981-07-20 |
Legacy Summary#
summary
FDA Review#
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