The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Medtronic(r) 8.2 French Sherpa(r) Super Peak Flow(tm) Coronary Guiding Catheter.
| Device ID | K950026 |
| 510k Number | K950026 |
| Device Name: | MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Joseph O Maglioozzi |
| Correspondent | Joseph O Maglioozzi 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 | 1995-01-04 |
| Decision Date | 1995-04-05 |