The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Gt2 Fusion Guide Wire, Model Ntlhlj180,ntlhls180, Ntlhlj300, Ntlhls300.
| Device ID | K001969 |
| 510k Number | K001969 |
| Device Name: | GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Fred L Boucher |
| Correspondent | Fred L Boucher MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-28 |
| Decision Date | 2000-08-16 |