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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 a medical device manufactured by Xtreem Pulse, LLC. It received FDA 510(k) clearance on 2018-05-30 under approval 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. It is manufactured by Xtreem Pulse, LLC. The 510(k) number is K173483.

When was Pure Flow External Counter-Pulsation Device approved by the FDA?

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

What company makes Pure Flow External Counter-Pulsation Device?

Pure Flow External Counter-Pulsation Device is manufactured by Xtreem Pulse, LLC.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41613162 Evaluating Translational AI: A Two-Way Moving Target Problem. NEJM AI (2025) PMID: 40920948 [The internal condom: overview, practical aspects and analysis of the barriers to its use]. Medecine sciences : M/S (2025)

Other Devices by Xtreem Pulse, LLC

K190269PureLift K221443PureLift Pro Plus K243587PureLift GLOW

Related Devices (Code: DRN)

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

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