Venera 508 Deep Vein Thrombosis (DVT) Prevention System

FDA 510(k) K180389 · Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

Substantially Equivalent

510(k) numberK180389

Submission

Device name
Venera 508 Deep Vein Thrombosis (DVT) Prevention System
Applicant
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
Suzhou, CN
Received
February 13, 2018
Decision date
June 29, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOW – Sleeve, Limb, Compressible
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5800
Specialty
Cardiovascular

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More from Manamed, LLC

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Questions and answers

When was Venera 508 Deep Vein Thrombosis (DVT) Prevention System cleared by the FDA?

Venera 508 Deep Vein Thrombosis (DVT) Prevention System (K180389) received a 510(k) decision of Substantially Equivalent on June 29, 2018, 136 days after the submission was received.

What is the product code of K180389?

The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.