The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Agilis Nxt Steerable Introducer, Model G408322 And G408323.
| Device ID | K083402 |
| 510k Number | K083402 |
| Device Name: | AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Mac Mckeen |
| Correspondent | Mac Mckeen ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-18 |
| Decision Date | 2008-12-15 |
| Summary: | summary |