The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Introducer Assembly With Rotator Lock.
| Device ID | K060519 |
| 510k Number | K060519 |
| Device Name: | INTRODUCER ASSEMBLY WITH ROTATOR LOCK |
| Classification | Introducer, Catheter |
| Applicant | TELEFLEX MEDICAL 2345 WAUKEGAN ROAD SUITE 140 Bannockburn, IL 60015 |
| Contact | Lori Hays |
| Correspondent | Lori Hays TELEFLEX MEDICAL 2345 WAUKEGAN ROAD SUITE 140 Bannockburn, IL 60015 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-27 |
| Decision Date | 2006-05-05 |
| Summary: | summary |