The following data is part of a premarket notification filed by Abbott Vascular Devices with the FDA for The Emboshield Embolic Protection System.
| Device ID | K052454 |
| 510k Number | K052454 |
| Device Name: | THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | ABBOTT VASCULAR DEVICES 400 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Debbie Cogan |
| Correspondent | Debbie Cogan ABBOTT VASCULAR DEVICES 400 SAGINAW DR. Redwood City, CA 94063 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-06 |
| Decision Date | 2005-09-14 |
| Summary: | summary |