The following data is part of a premarket notification filed by Ev3 Inc. with the FDA for 5mm Protege Everflex Self Expanding Biliary Stent System, Model Prp35-05.
| Device ID | K072301 |
| 510k Number | K072301 |
| Device Name: | 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | EV3 INC. 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920 |
| Contact | David Worrell |
| Correspondent | David Worrell EV3 INC. 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-17 |
| Decision Date | 2008-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684068625 | K072301 | 000 |
| 00821684034163 | K072301 | 000 |
| 00821684034156 | K072301 | 000 |
| 00821684034149 | K072301 | 000 |
| 00821684034132 | K072301 | 000 |
| 00821684034125 | K072301 | 000 |
| 00821684034118 | K072301 | 000 |
| 00821684034101 | K072301 | 000 |
| 00821684033746 | K072301 | 000 |
| 00821684033739 | K072301 | 000 |
| 00821684033722 | K072301 | 000 |
| 00821684033715 | K072301 | 000 |
| 00821684033708 | K072301 | 000 |
| 00821684042991 | K072301 | 000 |
| 00821684068496 | K072301 | 000 |
| 00821684068618 | K072301 | 000 |
| 00821684068601 | K072301 | 000 |
| 00821684068595 | K072301 | 000 |
| 00821684068588 | K072301 | 000 |
| 00821684068571 | K072301 | 000 |
| 00821684068564 | K072301 | 000 |
| 00821684068557 | K072301 | 000 |
| 00821684068540 | K072301 | 000 |
| 00821684068533 | K072301 | 000 |
| 00821684068526 | K072301 | 000 |
| 00821684068519 | K072301 | 000 |
| 00821684068502 | K072301 | 000 |
| 00821684033692 | K072301 | 000 |