Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more— 510(k) K220773
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K220773 for Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more, Substantially Equivalent on 2022-04-13. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Device name as filed
- 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. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
- Applicant
- Medtronic Vascular
- Product code
- Code MAV
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Danvers, MA, US
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Adverse events under product code MAV
product code MAV- Malfunction
- 1,433
- Total
- 1,433
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.