The following data is part of a premarket notification filed by Ev3 Inc. with the FDA for Spiderx Embolic Protection Device.
| Device ID | K053195 |
| 510k Number | K053195 |
| Device Name: | SPIDERX EMBOLIC PROTECTION DEVICE |
| Classification | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Applicant | EV3 INC. 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920 |
| Contact | Brenda Johnson |
| Correspondent | Brenda Johnson EV3 INC. 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920 |
| Product Code | NFA |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-15 |
| Decision Date | 2006-06-23 |
| Summary: | summary |