The following data is part of a premarket notification filed by Sulzer Intratherapeutics, Inc. with the FDA for Modification To Protege Self-expanding Nitinol Stent With Starport Delivery Technology.
| Device ID | K021729 |
| 510k Number | K021729 |
| Device Name: | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | SULZER INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 -3495 |
| Contact | Maria E Brittle |
| Correspondent | Maria E Brittle SULZER INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 -3495 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-24 |
| Decision Date | 2002-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684071786 | K021729 | 000 |
| 00821684071502 | K021729 | 000 |
| 00821684071519 | K021729 | 000 |
| 00821684071526 | K021729 | 000 |
| 00821684071533 | K021729 | 000 |
| 00821684071540 | K021729 | 000 |
| 00821684071557 | K021729 | 000 |
| 00821684071564 | K021729 | 000 |
| 00821684071571 | K021729 | 000 |
| 00821684071496 | K021729 | 000 |
| 00821684071489 | K021729 | 000 |
| 00821684071403 | K021729 | 000 |
| 00821684071410 | K021729 | 000 |
| 00821684071427 | K021729 | 000 |
| 00821684071434 | K021729 | 000 |
| 00821684071441 | K021729 | 000 |
| 00821684071458 | K021729 | 000 |
| 00821684071465 | K021729 | 000 |
| 00821684071472 | K021729 | 000 |
| 00821684071588 | K021729 | 000 |
| 00821684071595 | K021729 | 000 |
| 00821684071700 | K021729 | 000 |
| 00821684071717 | K021729 | 000 |
| 00821684071724 | K021729 | 000 |
| 00821684071731 | K021729 | 000 |
| 00821684071748 | K021729 | 000 |
| 00821684071755 | K021729 | 000 |
| 00821684071762 | K021729 | 000 |
| 00821684071779 | K021729 | 000 |
| 00821684071694 | K021729 | 000 |
| 00821684071687 | K021729 | 000 |
| 00821684071601 | K021729 | 000 |
| 00821684071618 | K021729 | 000 |
| 00821684071625 | K021729 | 000 |
| 00821684071632 | K021729 | 000 |
| 00821684071649 | K021729 | 000 |
| 00821684071656 | K021729 | 000 |
| 00821684071663 | K021729 | 000 |
| 00821684071670 | K021729 | 000 |
| 00821684071397 | K021729 | 000 |