The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Reflexion Hd High-density Mapping Catheter.
| Device ID | K080179 |
| 510k Number | K080179 |
| Device Name: | REFLEXION HD HIGH-DENSITY MAPPING CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Andrea Hudack |
| Correspondent | Andrea Hudack ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-24 |
| Decision Date | 2009-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734217262 | K080179 | 000 |