The following data is part of a premarket notification filed by Lumend, Inc. with the FDA for Lumend Frontrunner Gw Cto Catheter.
| Device ID | K031005 |
| 510k Number | K031005 |
| Device Name: | LUMEND FRONTRUNNER GW CTO CATHETER |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | LUMEND, INC. 400 CHESAPEAKE DR. Redwood City, CA 94063 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel LUMEND, INC. 400 CHESAPEAKE DR. Redwood City, CA 94063 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-06-18 |
| Summary: | summary |