The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Response Electrophysiology Catheter, Supreme Electrophysiology Catheter, Model 401xxx And 401xxx.
| Device ID | K002976 |
| 510k Number | K002976 |
| Device Name: | RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka, MN 55345 |
| Contact | Dean Bruhn-ding |
| Correspondent | Dean Bruhn-ding ST. JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka, MN 55345 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-25 |
| Decision Date | 2000-12-22 |