The following data is part of a premarket notification filed by St. Jude Medical, Daig Division, Inc. with the FDA for Agilis Steerable Catheter Introducer, Model 408304.
| Device ID | K042623 |
| 510k Number | K042623 |
| Device Name: | AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL, DAIG DIVISION, INC. 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Jennifer Nevison |
| Correspondent | Jennifer Nevison ST. JUDE MEDICAL, DAIG DIVISION, INC. 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 | 2004-09-27 |
| Decision Date | 2005-01-27 |
| Summary: | summary |