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FDA 510(k)

VPULSE

K-Number: K122640 · 2013-02-22

ApplicantCothera, LLC
Decision Date2013-02-22
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VPULSE is the device name listed in this FDA 510(k) record. The listed applicant is Cothera, LLC. It received FDA 510(k) clearance on 2013-02-22 under 510(k) number K122640. 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 VPULSE?

VPULSE is a medical device that received FDA 510(k) clearance on 2013-02-22. The listed applicant is Cothera, LLC. The 510(k) number is K122640.

When did VPULSE receive FDA 510(k) clearance?

VPULSE received FDA 510(k) clearance on 2013-02-22, under 510(k) number K122640.

Who is the listed applicant for VPULSE?

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

What is the FDA product code for VPULSE?

The FDA product code for VPULSE is JOW.

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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

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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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