The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Guardwire Temporary Occlusion And Aspiration System.
| Device ID | K023878 |
| 510k Number | K023878 |
| Device Name: | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM |
| Classification | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Fred L Boucher |
| Correspondent | Fred L Boucher MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | NFA |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-21 |
| Decision Date | 2003-01-24 |
| Summary: | summary |