The following data is part of a premarket notification filed by Ep Technologies, Inc. with the FDA for Torque Tube Steerocath(tm).
| Device ID | K913375 |
| 510k Number | K913375 |
| Device Name: | TORQUE TUBE STEEROCATH(TM) |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | EP TECHNOLOGIES, INC. 897 INDEPENDENCE AVE. SUITE 1- D Mountain View, CA 94043 |
| Contact | Linda Cooperman |
| Correspondent | Linda Cooperman EP TECHNOLOGIES, INC. 897 INDEPENDENCE AVE. SUITE 1- D Mountain View, CA 94043 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1991-10-25 |