The following data is part of a premarket notification filed by Cordis Corporation, A Johnson & Johnson Company with the FDA for Elitecross Support Catheter.
| Device ID | K150187 |
| 510k Number | K150187 |
| Device Name: | ELITECROSS Support Catheter |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | Cordis Corporation, A Johnson & Johnson Company 6500 Paseo Padre Parkway Fremont, CA 94555 |
| Contact | Michelle Ragozzino Rodgers |
| Correspondent | Michelle Ragozzino Rodgers Cordis Corporation, A Johnson & Johnson Company 6500 Paseo Padre Parkway 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 | 2015-01-27 |
| Decision Date | 2015-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032067536 | K150187 | 000 |
| 20705032067512 | K150187 | 000 |
| 20705032067505 | K150187 | 000 |
| 20705032067482 | K150187 | 000 |