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FDA 510(k)

CARDIASSIST EXTERNAL COUNTERPULSATION

K-Number: K792430 · 1980-01-23

ApplicantCardiassist Corp.
Decision Date1980-01-23
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIASSIST EXTERNAL COUNTERPULSATION is the device name listed in this FDA 510(k) record. The listed applicant is Cardiassist Corp.. It received FDA 510(k) clearance on 1980-01-23 under 510(k) number K792430. 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 EXTERNAL COUNTERPULSATION?

CARDIASSIST EXTERNAL COUNTERPULSATION is a medical device that received FDA 510(k) clearance on 1980-01-23. The listed applicant is Cardiassist Corp.. The 510(k) number is K792430.

When did CARDIASSIST EXTERNAL COUNTERPULSATION receive FDA 510(k) clearance?

CARDIASSIST EXTERNAL COUNTERPULSATION received FDA 510(k) clearance on 1980-01-23, under 510(k) number K792430.

Who is the listed applicant for CARDIASSIST EXTERNAL COUNTERPULSATION?

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

What is the FDA product code for CARDIASSIST EXTERNAL COUNTERPULSATION?

The FDA product code for CARDIASSIST EXTERNAL COUNTERPULSATION is DRN.

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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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