The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Array Multi-electrode Diagnostic Catheter.
| Device ID | K121006 |
| 510k Number | K121006 |
| Device Name: | ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Nicole Marwick |
| Correspondent | Nicole Marwick ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Product Code | MTD |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-03 |
| Decision Date | 2012-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15414734215661 | K121006 | 000 |
| 05414734215664 | K121006 | 000 |