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FDA 510(k)

CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000

K-Number: K050172 · 2005-03-31

ApplicantCardiomedics, Inc.
Decision Date2005-03-31
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiomedics, Inc.. It received FDA 510(k) clearance on 2005-03-31 under 510(k) number K050172. 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 CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000?

CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 is a medical device that received FDA 510(k) clearance on 2005-03-31. The listed applicant is Cardiomedics, Inc.. The 510(k) number is K050172.

When did CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 receive FDA 510(k) clearance?

CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 received FDA 510(k) clearance on 2005-03-31, under 510(k) number K050172.

Who is the listed applicant for CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000?

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

What is the FDA product code for CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000?

The FDA product code for CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 is DRN.

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Other records listing Cardiomedics, 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.

K023427CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000K022107CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000K010261CARDIOMEDICS ECP SYSTEMK872034CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM

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.K173483Pure Flow External Counter-Pulsation DeviceXtreem Pulse, LLCK130439EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORINGChongqing Psk Sci-Tech Development Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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