Cleared Special

K220773 - Everest 20 Inflation Device and 3-way Stopcock (AC2200) (FDA 510(k) Clearance)

Also includes:
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)
K220773 · Medtronic Vascular · Cardiovascular device
Apr 2022
Decision
28d
Days
Class 2
Risk

K220773 is an FDA 510(k) clearance for the Everest 20 Inflation Device and 3-way Stopcock (AC2200). This device is classified as a Syringe, Balloon Inflation (Class II - Special Controls, product code MAV).

Submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on April 13, 2022, 28 days after receiving the submission on March 16, 2022.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K220773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2022
Decision Date April 13, 2022
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MAV — Syringe, Balloon Inflation
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.1650