The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Agilis Es Steerable Introducer.
| Device ID | K103083 |
| 510k Number | K103083 |
| Device Name: | AGILIS ES STEERABLE INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | Laura Moen-ftacek |
| Correspondent | Laura Moen-ftacek ST. JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-19 |
| Decision Date | 2011-04-08 |
| Summary: | summary |