The following data is part of a premarket notification filed by Pathfinder Therapeutics, Inc. with the FDA for Explorer Liver (passive Tracking).
| Device ID | K101979 |
| 510k Number | K101979 |
| Device Name: | EXPLORER LIVER (PASSIVE TRACKING) |
| Classification | Tracking, Soft Tissue, Intraoperative |
| Applicant | PATHFINDER THERAPEUTICS, INC. 2969 ARMORY DR. SUITE 100A Nashville, TN 37204 |
| Contact | Senhu Li |
| Correspondent | Senhu Li PATHFINDER THERAPEUTICS, INC. 2969 ARMORY DR. SUITE 100A Nashville, TN 37204 |
| Product Code | OEW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-14 |
| Decision Date | 2011-02-09 |
| Summary: | summary |