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FDA 510(k)

Pure Flow External Counter-Pulsation Device

K-Number: K173483 · 2018-05-30

ApplicantXtreem Pulse, LLC
Decision Date2018-05-30
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pure Flow External Counter-Pulsation Device is the device name listed in this FDA 510(k) record. The listed applicant is Xtreem Pulse, LLC. It received FDA 510(k) clearance on 2018-05-30 under 510(k) number K173483. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pure Flow External Counter-Pulsation Device?

Pure Flow External Counter-Pulsation Device is a medical device that received FDA 510(k) clearance on 2018-05-30. The listed applicant is Xtreem Pulse, LLC. The 510(k) number is K173483.

When did Pure Flow External Counter-Pulsation Device receive FDA 510(k) clearance?

Pure Flow External Counter-Pulsation Device received FDA 510(k) clearance on 2018-05-30, under 510(k) number K173483.

Who is the listed applicant for Pure Flow External Counter-Pulsation Device?

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

What is the FDA product code for Pure Flow External Counter-Pulsation Device?

The FDA product code for Pure Flow External Counter-Pulsation Device is DRN.

Other records listing Xtreem Pulse, LLC 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.

K243587PureLift GLOWK230506PureLift Pro EditionK221443PureLift Pro PlusK190269PureLift

Related Devices (Code: DRN)

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.

K250756Pression Wave PRO External Counter-Pulsation SystemPression, Inc.K202108External Counterpulsation System, SoulaireVamed Medical Instrument Co., Ltd.K191955Enhanced External Counter Pulsation Device Plus Omay-AOmay(Guangzhou)Med Technologies Co., Ltd.K190683External Counterpulsation SystemVamed Medical Instrument 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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