The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Angioguard Xp Emboli Capture Guidewire, Angioguard Rx Emboli Capture Guidewire.
| Device ID | K220654 |
| 510k Number | K220654 |
| Device Name: | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
| Contact | Dunia Bram |
| Correspondent | Dunia Bram Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-04-06 |