Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AlphaVac Multipurpose Mechanical Aspiration (MMA) System

K-Number: K211081 · 2021-06-04

ApplicantAngioDynamics, Inc.
Decision Date2021-06-04
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AlphaVac Multipurpose Mechanical Aspiration (MMA) System is a medical device manufactured by AngioDynamics, Inc.. It received FDA 510(k) clearance on 2021-06-04 under approval number K211081. 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) System?

AlphaVac Multipurpose Mechanical Aspiration (MMA) System is a medical device that received FDA 510(k) clearance on 2021-06-04. It is manufactured by AngioDynamics, Inc.. The 510(k) number is K211081.

When was AlphaVac Multipurpose Mechanical Aspiration (MMA) System approved by the FDA?

AlphaVac Multipurpose Mechanical Aspiration (MMA) System received FDA 510(k) clearance on 2021-06-04, under approval number K211081.

What company makes AlphaVac Multipurpose Mechanical Aspiration (MMA) System?

AlphaVac Multipurpose Mechanical Aspiration (MMA) System is manufactured by AngioDynamics, Inc..

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

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

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT07356284 Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING

Related PubMed Literature

PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by AngioDynamics, Inc.

K162914VenaCure EVLT NeverTouch Procedure Kit K171921VenaCure EVLT NeverTouch Procedure Kit K170775Mini Stick ENVI Non-Vascular Introducer Kit K170695VenaCure EVLT NeverTouch Direct Introducer Sheath K163356Pulse* Spray Infusion System, Uni*Fuse Infusion System K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)

View all 28 devices →

Related Devices (Code: QEZ)

K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC K173266Octane aspiration systemVascular Solutions, Inc. K172000ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC K182232Octane Mechanical Thrombectomy SystemVascular Solutions, Inc. K192439JETi Peripheral Thrombectomy SystemWalk Vascular, LLC

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.

↑