The following data is part of a premarket notification filed by Cordis Corp., A Johnson & Johnson Co. with the FDA for Angioguard Xp Emboli Capture Guidewire And Angioguard Rx Emboli Capture Guidewire.
| Device ID | K062531 |
| 510k Number | K062531 |
| Device Name: | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | CORDIS CORP., A JOHNSON & JOHNSON CO. 7 POWDERHORN DRIVE Warren, NJ 07059 |
| Contact | Joan Martin |
| Correspondent | Joan Martin CORDIS CORP., A JOHNSON & JOHNSON CO. 7 POWDERHORN DRIVE Warren, NJ 07059 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-29 |
| Decision Date | 2006-09-22 |
| Summary: | summary |