The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Micro Guide Catheter Xp.
| Device ID | K082143 |
| 510k Number | K082143 |
| Device Name: | MICRO GUIDE CATHETER XP |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Karen Wilk |
| Correspondent | Karen Wilk CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-30 |
| Decision Date | 2008-08-25 |
| Summary: | summary |