The following data is part of a premarket notification filed by Tfx Medical Group with the FDA for Tfx Medical Guidewire.
| Device ID | K963320 |
| 510k Number | K963320 |
| Device Name: | TFX MEDICAL GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | TFX MEDICAL GROUP TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong TFX MEDICAL GROUP 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 | 1996-08-23 |
| Decision Date | 1996-12-03 |
| Summary: | summary |