The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Angioguard Xp Emboli Capture Guidewire, Angioguard Rx Emboli Capture Guidewire.
| Device ID | K101651 |
| 510k Number | K101651 |
| Device Name: | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE |
| Classification | Temporary Carotid Catheter For Embolic Capture |
| Applicant | CORDIS CORP. 430 ROUTE 22 EAST Bridgewater, NJ 08807 |
| Contact | Joan Martin |
| Correspondent | Joan Martin CORDIS CORP. 430 ROUTE 22 EAST Bridgewater, NJ 08807 |
| Product Code | NTE |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-11 |
| Decision Date | 2010-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032056721 | K101651 | 000 |
| 20705032054789 | K101651 | 000 |