The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Spiderfx Embolic Protection Device.
| Device ID | K063785 |
| 510k Number | K063785 |
| Device Name: | SPIDERFX EMBOLIC PROTECTION DEVICE |
| Classification | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Applicant | EV3 INC 9600 54TH AVENUE NORTH Plymouth, MN 55442 -2111 |
| Contact | David Worrell |
| Correspondent | David Worrell EV3 INC 9600 54TH AVENUE NORTH Plymouth, MN 55442 -2111 |
| Product Code | NFA |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-21 |
| Decision Date | 2007-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684040522 | K063785 | 000 |
| 00821684040348 | K063785 | 000 |
| 00821684040355 | K063785 | 000 |
| 00821684040362 | K063785 | 000 |
| 00821684040379 | K063785 | 000 |
| 00821684040485 | K063785 | 000 |
| 00821684040492 | K063785 | 000 |
| 00821684040508 | K063785 | 000 |
| 00821684040515 | K063785 | 000 |
| 00821684040331 | K063785 | 000 |