The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Teleflex Guidewire.
| Device ID | K850677 |
| 510k Number | K850677 |
| Device Name: | TELEFLEX GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-21 |
| Decision Date | 1985-09-17 |