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FDA 510(k)

CIRCUFLOW 5150

K-Number: K123959 · 2013-02-28

ApplicantDevon Medical, Inc.
Decision Date2013-02-28
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CIRCUFLOW 5150 is the device name listed in this FDA 510(k) record. The listed applicant is Devon Medical, Inc.. It received FDA 510(k) clearance on 2013-02-28 under 510(k) number K123959. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCUFLOW 5150?

CIRCUFLOW 5150 is a medical device that received FDA 510(k) clearance on 2013-02-28. The listed applicant is Devon Medical, Inc.. The 510(k) number is K123959.

When did CIRCUFLOW 5150 receive FDA 510(k) clearance?

CIRCUFLOW 5150 received FDA 510(k) clearance on 2013-02-28, under 510(k) number K123959.

Who is the listed applicant for CIRCUFLOW 5150?

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

What is the FDA product code for CIRCUFLOW 5150?

The FDA product code for CIRCUFLOW 5150 is JOW.

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Other records listing Devon Medical, 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.

K131464EXTRICARE NPWT FOOT DRESSINGK131743CIRONA DVT FOOT GARMENTK130571DEVON CIRONA 6100 DVTK123647CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICEK102582ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICEK101523CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE

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Related Devices (Code: JOW)

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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , 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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