The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Paramount Mini Gps Biliary Stent System.
| Device ID | K040653 |
| 510k Number | K040653 |
| Device Name: | PARAMOUNT MINI GPS BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | EV3 INC 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920 |
| Contact | Maria E Brittle |
| Correspondent | Maria E Brittle EV3 INC 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-12 |
| Decision Date | 2004-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684006641 | K040653 | 000 |
| 00821684006399 | K040653 | 000 |
| 00821684006405 | K040653 | 000 |
| 00821684006412 | K040653 | 000 |
| 00821684006429 | K040653 | 000 |
| 00821684006436 | K040653 | 000 |
| 00821684006443 | K040653 | 000 |
| 00821684006450 | K040653 | 000 |
| 00821684006467 | K040653 | 000 |
| 00821684006566 | K040653 | 000 |
| 00821684006573 | K040653 | 000 |
| 00821684006580 | K040653 | 000 |
| 00821684006597 | K040653 | 000 |
| 00821684006603 | K040653 | 000 |
| 00821684006610 | K040653 | 000 |
| 00821684006627 | K040653 | 000 |
| 00821684006634 | K040653 | 000 |
| 00821684006382 | K040653 | 000 |