The following data is part of a premarket notification filed by Teleflex, Inc. with the FDA for Percutaneous Introducer Kit.
| Device ID | K123974 |
| 510k Number | K123974 |
| Device Name: | PERCUTANEOUS INTRODUCER KIT |
| Classification | Introducer, Catheter |
| Applicant | TELEFLEX, INC. 50 PLANTATION DR. Jaffrey, NH 03452 |
| Contact | Dawn L Moore |
| Correspondent | Dawn L Moore TELEFLEX, INC. 50 PLANTATION DR. Jaffrey, NH 03452 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-02-21 |
| Summary: | summary |