The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Over The Needle Splitable Catheter Assembly Type 1.
| Device ID | K920908 |
| 510k Number | K920908 |
| Device Name: | OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1 |
| Classification | Introducer, Catheter |
| Applicant | Teleflex Medical, Inc. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Jo Rudziensky |
| Correspondent | Jo Rudziensky Teleflex Medical, Inc. TALL PINES PARK 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 | 1992-02-27 |
| Decision Date | 1992-10-06 |