The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Trivex System.
| Device ID | K032387 |
| 510k Number | K032387 |
| Device Name: | TRIVEX SYSTEM |
| Classification | Stripper, Vein, External |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Karen Provencher |
| Correspondent | Karen Provencher SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | DWQ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663107391 | K032387 | 000 |
| 00840663106530 | K032387 | 000 |
| 00840663106547 | K032387 | 000 |
| 00840663106554 | K032387 | 000 |
| 00840663106561 | K032387 | 000 |
| 00840663106578 | K032387 | 000 |
| 00840663106585 | K032387 | 000 |
| 00840663106592 | K032387 | 000 |
| 00840663106608 | K032387 | 000 |
| 00840663106615 | K032387 | 000 |
| 00840663106622 | K032387 | 000 |
| 00840663106639 | K032387 | 000 |
| 00840663106646 | K032387 | 000 |
| 00840663106738 | K032387 | 000 |
| 00840663106523 | K032387 | 000 |