FDA 510(k)

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

K-Number: K213388 · 2022-04-04

Decision Date2022-04-04

Product CodeQEZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2022-04-04 under 510(k) number K213388. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System?

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is a medical device that received FDA 510(k) clearance on 2022-04-04. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K213388.

When did AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System receive FDA 510(k) clearance?

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System received FDA 510(k) clearance on 2022-04-04, under 510(k) number K213388.

Who is the listed applicant for AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System?

The FDA 510(k) record lists AngioDynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System?

The FDA product code for AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is QEZ.

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Other records listing AngioDynamics, Inc. as applicant

K253198NanoKnife Generator (H78720300351US0)K252509AlphaVac Multipurpose Mechanical Aspiration System F1885 K253106AngioVac Cannula K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)K240397AlphaVac MMA F1885 System (H787253020)K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits

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Related Devices (Code: QEZ)

K261105Powered Aventus Thrombectomy System™Inquis Medical K262030Aventus Thrombectomy SystemInquis Medical K253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc.K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.K253925Aventus Thrombectomy SystemInquis Medical K252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.