The following data is part of a premarket notification filed by Cordis Corp., A Johnson & Johnson Co. with the FDA for Micro Guide Catheter Elite.
| Device ID | K140438 |
| 510k Number | K140438 |
| Device Name: | MICRO GUIDE CATHETER ELITE |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | CORDIS CORP., A JOHNSON & JOHNSON CO. 6500 PASEO PADRE PKWY. Fremont, CA 94555 |
| Contact | Michelle Ragozzine Rodgers |
| Correspondent | Michelle Ragozzine Rodgers CORDIS CORP., A JOHNSON & JOHNSON CO. 6500 PASEO PADRE PKWY. Fremont, CA 94555 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-21 |
| Decision Date | 2014-11-14 |
| Summary: | summary |