The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Metronic Buchbinder Envoy Percutaneous Catheters.
| Device ID | K935425 |
| 510k Number | K935425 |
| Device Name: | METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 9410 CARROLL PARK DR. San Diego, CA 92121 -2256 |
| Contact | Timothy J Johnson |
| Correspondent | Timothy J Johnson MEDTRONICS INTERVENTIONAL VASCULAR 9410 CARROLL PARK DR. San Diego, CA 92121 -2256 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-10 |
| Decision Date | 1994-04-26 |