The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Everest 20 Inflation Device And 3-way Stopcock (ac2200);everest 30 Inflation Device And 3-way Stopcock (ac3200);everest 20 Survival Kit Containing:1. Everest 20 Device With 3-way Stopcock, 2. Piton Y-adaptor ,3. Metal Guidewire Insertion Needle, 4. T.
| Device ID | K220773 |
| 510k Number | K220773 |
| Device Name: | Everest 20 Inflation Device And 3-way Stopcock (AC2200);Everest 30 Inflation Device And 3-way Stopcock (AC3200);Everest 20 Survival Kit Containing:1. Everest 20 Device With 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. T |
| Classification | Syringe, Balloon Inflation |
| Applicant | Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923 |
| Contact | Nikita Ciandra Vaz |
| Correspondent | Nikita Ciandra Vaz Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-16 |
| Decision Date | 2022-04-13 |