The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Agilis Nxt Steerable Introducer.
| Device ID | K061363 |
| 510k Number | K061363 |
| Device Name: | AGILIS NXT STEERABLE INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Glenn Jacques |
| Correspondent | Glenn Jacques 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 | 2006-05-16 |
| Decision Date | 2006-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067000255 | K061363 | 000 |
| 05414734206105 | K061363 | 000 |
| 05414734206112 | K061363 | 000 |
| 05414734206129 | K061363 | 000 |
| 05414734206136 | K061363 | 000 |
| 05414734206143 | K061363 | 000 |
| 05414734206167 | K061363 | 000 |
| 05414734206174 | K061363 | 000 |
| 05414734206181 | K061363 | 000 |
| 05414734206198 | K061363 | 000 |
| 05414734206099 | K061363 | 000 |