The following data is part of a premarket notification filed by Endo-therapeutics, Inc. with the FDA for Endocath Electrophysiology Catheter.
| Device ID | K926549 |
| 510k Number | K926549 |
| Device Name: | ENDOCATH ELECTROPHYSIOLOGY CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ENDO-THERAPEUTICS, INC. 1380 ENERGY LN. SUITE 110 St. Paul, MN 55108 |
| Contact | Jeffrey R Budd |
| Correspondent | Jeffrey R Budd ENDO-THERAPEUTICS, INC. 1380 ENERGY LN. SUITE 110 St. Paul, MN 55108 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-31 |
| Decision Date | 1993-12-06 |