The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ultimum Ev Hemostasis Introducer.
| Device ID | K140327 |
| 510k Number | K140327 |
| Device Name: | ULTIMUM EV HEMOSTASIS INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 5050 NATHAN LANE N Plymouth, MN 55442 |
| Contact | Loucinda Bjorklund |
| Correspondent | Loucinda Bjorklund ST. JUDE MEDICAL 5050 NATHAN LANE N Plymouth, MN 55442 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-10 |
| Decision Date | 2014-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067014382 | K140327 | 000 |