The following data is part of a premarket notification filed by Abbott Vascular-vascular Solutions with the FDA for Emboshield Nav6 Embolic Protection System-small/large, Model 22437-19/22438-19.
| Device ID | K090665 |
| 510k Number | K090665 |
| Device Name: | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19 |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | ABBOTT VASCULAR-VASCULAR SOLUTIONS 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | Danielle Taylor |
| Correspondent | Danielle Taylor ABBOTT VASCULAR-VASCULAR SOLUTIONS 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-13 |
| Decision Date | 2009-05-22 |