The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Agilis Nxt Steerable Introducer.
| Device ID | K110450 |
| 510k Number | K110450 |
| Device Name: | AGILIS NXT STEERABLE INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka, MN 55345 |
| Contact | Wendy Pinor |
| Correspondent | Wendy Pinor ST. JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka, MN 55345 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-16 |
| Decision Date | 2011-05-10 |
| Summary: | summary |