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FDA 510(k)

THE VENOUS ASSIST SYSTEM

K-Number: K112677 · 2012-01-13

ApplicantDaesung Maref Co., Ltd.
Decision Date2012-01-13
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE VENOUS ASSIST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2012-01-13 under 510(k) number K112677. 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 THE VENOUS ASSIST SYSTEM?

THE VENOUS ASSIST SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-13. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K112677.

When did THE VENOUS ASSIST SYSTEM receive FDA 510(k) clearance?

THE VENOUS ASSIST SYSTEM received FDA 510(k) clearance on 2012-01-13, under 510(k) number K112677.

Who is the listed applicant for THE VENOUS ASSIST SYSTEM?

The FDA 510(k) record lists Daesung Maref Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE VENOUS ASSIST SYSTEM?

The FDA product code for THE VENOUS ASSIST SYSTEM is JOW.

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Other records listing Daesung Maref Co., Ltd. as applicant

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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.

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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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