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FDA 510(k)

PlasmaFlow

K-Number: K160318 · 2016-04-01

ApplicantManamed, Inc.
Decision Date2016-04-01
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PlasmaFlow is the device name listed in this FDA 510(k) record. The listed applicant is Manamed, Inc.. It received FDA 510(k) clearance on 2016-04-01 under 510(k) number K160318. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PlasmaFlow?

PlasmaFlow is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Manamed, Inc.. The 510(k) number is K160318.

When did PlasmaFlow receive FDA 510(k) clearance?

PlasmaFlow received FDA 510(k) clearance on 2016-04-01, under 510(k) number K160318.

Who is the listed applicant for PlasmaFlow?

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

What is the FDA product code for PlasmaFlow?

The FDA product code for PlasmaFlow is JOW.

Other records listing Manamed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260944ManaCold Compression SystemK251446PlasmaFlow X Compression Sleeve Device (XPF0001)K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)K222098ManaSport+K210284ManaSportK211253PlasmaWave

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Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,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.

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