The following data is part of a premarket notification filed by Cordis Corporation, A Johnson & Johnson Co. with the FDA for Outback Elite Re-entry Catheter.
| Device ID | K150836 |
| 510k Number | K150836 |
| Device Name: | OUTBACK Elite Re-Entry Catheter |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | CORDIS CORPORATION, A JOHNSON & JOHNSON CO. 6500 PASEO PADRE PARKWAY Fremont, CA 94555 |
| Contact | Michelle Ragozzino Rodgers |
| Correspondent | Michelle Ragozzino Rodgers CORDIS CORPORATION, A JOHNSON & JOHNSON CO. 6500 PASEO PADRE PARKWAY Fremont, CA 94555 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-30 |
| Decision Date | 2015-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032067574 | K150836 | 000 |
| 20705032067567 | K150836 | 000 |