The following data is part of a premarket notification filed by Ep Medsystems, Inc. with the FDA for Ep Deflectable Catheters.
| Device ID | K033963 |
| 510k Number | K033963 |
| Device Name: | EP DEFLECTABLE CATHETERS |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | EP MEDSYSTEMS, INC. COOPER RUN EXECUTIVE PARK 575 ROUTE 73 NORTH, BUILDING D West Berlin, NJ 08091 -9293 |
| Contact | James E Kuhn, Jr. |
| Correspondent | James E Kuhn, Jr. EP MEDSYSTEMS, INC. COOPER RUN EXECUTIVE PARK 575 ROUTE 73 NORTH, BUILDING D West Berlin, NJ 08091 -9293 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-04-15 |