The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Response Electrophysiology Catheters With Lumen.
| Device ID | K120544 |
| 510k Number | K120544 |
| Device Name: | RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Marlene Peterson |
| Correspondent | Marlene Peterson 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 | 2012-02-23 |
| Decision Date | 2012-03-19 |
| Summary: | summary |