Pure Flow External Counter-Pulsation Device

Q: What is the product code of K173483?

The FDA product code is DRN – Device, Counter-Pulsating, External, a Class II (moderate risk) device regulated under 21 CFR 870.5225.

FDA 510(k) K173483 · Xtreem Pulse, LLC

Substantially Equivalent

510(k) numberK173483

Submission

Device name: Pure Flow External Counter-Pulsation Device
Applicant: Xtreem Pulse, LLC
New York, NY, US
Received: November 13, 2017
Decision date: May 30, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DRN – Device, Counter-Pulsating, External
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.5225
Specialty: Cardiovascular

Other 510(k)s with product code DRN

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K191955	Enhanced External Counter Pulsation Device Plus Omay-ADRN · Traditional	Omay(Guangzhou)Med Technologies Co., Ltd.	08/05/2020SE
K190683	External Counterpulsation SystemDRN · Traditional	Vamed Medical Instrument Co., Ltd.	09/10/2019SE
K152115	Renew NCP-5 External Counterpulsation SystemDRN · Traditional	Stage 2 Innovations	12/17/2015SE
K130439	External Counterpulsation Device with SP02 MornitoringDRN · Traditional	Chongqing Psk Sci-Tech Development Co., Ltd.	12/12/2013SE
K082134	Circulator BootDRN · Traditional	Circulator Boot Corp.	05/07/2009SE
K081359	Genesis EcpDRN · Special	Scottcare Corporation	05/29/2008SE
K052611	Ecp Health System, Model 2005DRN · Traditional	Ecp Health, Inc.	04/26/2006SE
K050172	Cardiassist Counter Pulsation System Series 4000/5000DRN · Traditional	Cardiomedics, Inc.	03/31/2005SE

More from Cardiomedics, Inc.

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K230506	PureLift Pro EditionNFO · Special	06/21/2023SE
K221443	PureLift Pro PlusNFO · Special	10/21/2022SE
K190269	PureLiftNFO · Traditional	08/28/2019SE

Questions and answers

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

Pure Flow External Counter-Pulsation Device (K173483) received a 510(k) decision of Substantially Equivalent on May 30, 2018, 198 days after the submission was received.

What is the product code of K173483?

The FDA product code is DRN – Device, Counter-Pulsating, External, a Class II (moderate risk) device regulated under 21 CFR 870.5225.