The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Medtronic Gciii Coronary Guiding Catheter.
| Device ID | K935738 |
| 510k Number | K935738 |
| Device Name: | MEDTRONIC GCIII CORONARY GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Kenneth A Spector |
| Correspondent | Kenneth A Spector MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-01 |
| Decision Date | 1994-05-04 |