The following data is part of a premarket notification filed by Lumend, Inc. with the FDA for Outback Catheter.
| Device ID | K001577 |
| 510k Number | K001577 |
| Device Name: | OUTBACK CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | LUMEND, INC. 400 CHESAPEAKE DR. Redwood City, CA 94063 |
| Contact | Phil Hopper |
| Correspondent | Phil Hopper LUMEND, INC. 400 CHESAPEAKE DR. Redwood City, CA 94063 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-22 |
| Decision Date | 2001-01-11 |