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)

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

K-Number: K192838 · 2020-04-13

ApplicantSpectrum Medical , Ltd.
Decision Date2020-04-13
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure is a medical device manufactured by Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2020-04-13 under approval number K192838. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure?

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure is a medical device that received FDA 510(k) clearance on 2020-04-13. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K192838.

When was Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure approved by the FDA?

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure received FDA 510(k) clearance on 2020-04-13, under approval number K192838.

What company makes Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure?

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure is manufactured by Spectrum Medical , Ltd..

What is the FDA product code for Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure?

The FDA product code for Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure is DWA.

Related Clinical Trials

NCT07574229 Support System Design for Adolescent Scoliosis Orthosis Wear RECRUITING NCT06465225 Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress COMPLETED NCT07564258 Estimation of P0.1 Using Ultrasound Indexes of Diaphragm Function NOT_YET_RECRUITING NCT07257016 HFTO Via Tracheal Intubation in Neurocritical Patients COMPLETED NCT07530302 Treatment Failure of Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea Syndrome (OSA): A Trial Comparing Polysomnography and the Sunrise Device to Drive Treatment-Adjustment Decisions. NOT_YET_RECRUITING

Other Devices by Spectrum Medical , Ltd.

K163657Quantum Workstation K181942Quantum Ventilation Module K181923Quantum Workstation 12.1 K173834Quantum Pump Console K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

View all 12 devices →

Related Devices (Code: DWA)

K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott) K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula KitAbbott (Formerly Thoratec Corporation) K230698Anivia SG1000 Pump ConsoleApmtd, Inc. K221491Anivia SG1000 Pump ConsoleApmtd, Inc. K232788INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.

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.

↑