The following data is part of a premarket notification filed by Ep Technologies, Inc. with the FDA for Polaris X Catheters, Model 7000d,7001d,7003d,7004d,7005d,7006d.
| Device ID | K003452 |
| 510k Number | K003452 |
| Device Name: | POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | EP TECHNOLOGIES, INC. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Contact | Christina Rowe |
| Correspondent | Christina Rowe EP TECHNOLOGIES, INC. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-07 |
| Decision Date | 2000-12-07 |