The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Teleflex Medical Introducer Needle.
| Device ID | K851140 |
| 510k Number | K851140 |
| Device Name: | TELEFLEX MEDICAL INTRODUCER NEEDLE |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | Teleflex Medical, Inc. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Herbert M Carter |
| Correspondent | Herbert M Carter Teleflex Medical, Inc. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-21 |
| Decision Date | 1985-06-19 |