The following data is part of a premarket notification filed by Cordis Corp., A Johnson & Johnson Co. with the FDA for Outback Ltd Re-entry Catheter, Model: Otb42120.
| Device ID | K083814 |
| 510k Number | K083814 |
| Device Name: | OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | CORDIS CORP., A JOHNSON & JOHNSON CO. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Karen Wilk |
| Correspondent | Karen Wilk CORDIS CORP., A JOHNSON & JOHNSON CO. 7 POWDER HORN DR. Warren, NJ 07059 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032035016 | K083814 | 000 |