The following data is part of a premarket notification filed by St. Jude Medical with the FDA for 6f Evaluator Electrophysiology Catheter, Crd # 402720,402722; 6f Eavuator Electrophysisology Catheter, Jsn #402721, 4027.
| Device ID | K011766 |
| 510k Number | K011766 |
| Device Name: | 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Angela Byland |
| Correspondent | Angela Byland ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-07 |
| Decision Date | 2001-07-03 |
| Summary: | summary |