The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Engage/engage Tr Introducers.
| Device ID | K111092 |
| 510k Number | K111092 |
| Device Name: | ENGAGE/ENGAGE TR INTRODUCERS |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Venkata Damaraju |
| Correspondent | Venkata Damaraju 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 | 2011-04-19 |
| Decision Date | 2011-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15414734055946 | K111092 | 000 |
| 15414734052754 | K111092 | 000 |
| 15414734052778 | K111092 | 000 |
| 15414734052792 | K111092 | 000 |
| 15414734052815 | K111092 | 000 |
| 15414734052839 | K111092 | 000 |
| 15414734052853 | K111092 | 000 |
| 15414734052877 | K111092 | 000 |
| 15414734052891 | K111092 | 000 |
| 15414734052730 | K111092 | 000 |
| 15414734052716 | K111092 | 000 |
| 15414734030448 | K111092 | 000 |
| 15414734030462 | K111092 | 000 |
| 15414734030486 | K111092 | 000 |
| 15414734052570 | K111092 | 000 |
| 15414734052594 | K111092 | 000 |
| 15414734052617 | K111092 | 000 |
| 15414734052631 | K111092 | 000 |
| 15414734052693 | K111092 | 000 |
| 15414734052914 | K111092 | 000 |
| 15414734052938 | K111092 | 000 |
| 15414734053195 | K111092 | 000 |
| 15414734053539 | K111092 | 000 |
| 15414734053553 | K111092 | 000 |
| 15414734055847 | K111092 | 000 |
| 15414734055861 | K111092 | 000 |
| 15414734055885 | K111092 | 000 |
| 15414734055908 | K111092 | 000 |
| 15414734055922 | K111092 | 000 |
| 15414734053171 | K111092 | 000 |
| 15414734053157 | K111092 | 000 |
| 15414734052952 | K111092 | 000 |
| 15414734052976 | K111092 | 000 |
| 15414734053010 | K111092 | 000 |
| 15414734053034 | K111092 | 000 |
| 15414734053058 | K111092 | 000 |
| 15414734053096 | K111092 | 000 |
| 15414734053119 | K111092 | 000 |
| 15414734053133 | K111092 | 000 |
| 15414734030400 | K111092 | 000 |