The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ultimum/engage/engage Tr.
| Device ID | K091137 |
| 510k Number | K091137 |
| Device Name: | ULTIMUM/ENGAGE/ENGAGE TR |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Linh Pham |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-04-22 |
| Summary: | summary |