The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Spiderfx Embolic Protection Device.
| Device ID | K111010 |
| 510k Number | K111010 |
| Device Name: | SPIDERFX EMBOLIC PROTECTION DEVICE |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | EV3 INC 3033 Campus Drive Plymouth, MN 55441 |
| Contact | Brenda Johnson |
| Correspondent | Brenda Johnson EV3 INC 3033 Campus Drive Plymouth, MN 55441 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-11 |
| Decision Date | 2011-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684068380 | K111010 | 000 |
| 00821684068298 | K111010 | 000 |
| 00821684068304 | K111010 | 000 |
| 00821684068311 | K111010 | 000 |
| 00821684068328 | K111010 | 000 |
| 00821684068335 | K111010 | 000 |
| 00821684068342 | K111010 | 000 |
| 00821684068359 | K111010 | 000 |
| 00821684068366 | K111010 | 000 |
| 00821684068373 | K111010 | 000 |
| 00821684068106 | K111010 | 000 |