The following data is part of a premarket notification filed by Medtronic Ave, Inc. with the FDA for Medtronic, Inc. Racer Biliary Stent System (racer), Model Xd#yf(l).
| Device ID | K032768 |
| 510k Number | K032768 |
| Device Name: | MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDTRONIC AVE, INC. 3576 Unocal Place Santa Rosa, CA 95403 |
| Contact | Sarah Shephard |
| Correspondent | Sarah Shephard MEDTRONIC AVE, INC. 3576 Unocal Place Santa Rosa, CA 95403 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-08 |
| Decision Date | 2003-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994551580 | K032768 | 000 |
| 00613994551443 | K032768 | 000 |
| 00613994551450 | K032768 | 000 |
| 00613994551467 | K032768 | 000 |
| 00613994551474 | K032768 | 000 |
| 00613994551481 | K032768 | 000 |
| 00613994551498 | K032768 | 000 |
| 00613994551504 | K032768 | 000 |
| 00613994551511 | K032768 | 000 |
| 00613994551528 | K032768 | 000 |
| 00613994551535 | K032768 | 000 |
| 00613994551542 | K032768 | 000 |
| 00613994551559 | K032768 | 000 |
| 00613994551566 | K032768 | 000 |
| 00613994551573 | K032768 | 000 |
| 00613994551436 | K032768 | 000 |