The following data is part of a premarket notification filed by St. Jude Medical with the FDA for 6f Engage/engage Tr Introducer.
| Device ID | K101883 |
| 510k Number | K101883 |
| Device Name: | 6F ENGAGE/ENGAGE TR INTRODUCER |
| 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 | 2010-07-06 |
| Decision Date | 2010-09-07 |
| Summary: | summary |