The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Spiderfx Embolic Protection Device.
| Device ID | K063204 |
| 510k Number | K063204 |
| Device Name: | SPIDERFX EMBOLIC PROTECTION DEVICE |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | EV3 INC 9600 54TH AVENUE NORTH Plymouth, MN 55442 -2920 |
| Contact | David Worrell |
| Correspondent | David Worrell EV3 INC 9600 54TH AVENUE NORTH Plymouth, MN 55442 -2920 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-23 |
| Decision Date | 2006-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684068380 | K063204 | 000 |
| 00821684068304 | K063204 | 000 |
| 00821684068311 | K063204 | 000 |
| 00821684068328 | K063204 | 000 |
| 00821684068335 | K063204 | 000 |
| 00821684068342 | K063204 | 000 |
| 00821684068359 | K063204 | 000 |
| 00821684068366 | K063204 | 000 |
| 00821684068373 | K063204 | 000 |
| 00821684068298 | K063204 | 000 |