The following data is part of a premarket notification filed by Cardiofocus, Inc. with the FDA for Malleable Surgical Lightstic 180, Model 180 (1cm-9cm).
| Device ID | K013901 |
| 510k Number | K013901 |
| Device Name: | MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARDIOFOCUS, INC. 10 COMMERCE WAY Norton, MA 02766 |
| Contact | Joseph Curtis |
| Correspondent | Joseph Curtis CARDIOFOCUS, INC. 10 COMMERCE WAY Norton, MA 02766 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-26 |
| Decision Date | 2001-12-20 |
| Summary: | summary |