Cleared Traditional

K150980 - Venous Assist System

K150980 is an FDA 510(k) clearance for Venous Assist System, manufactured by Daesung Maref Co., Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K150980 · Daesung Maref Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2016
Decision
394d
Days
Class 2
Risk

K150980 is an FDA 510(k) clearance for the Venous Assist System. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Daesung Maref Co., Ltd. (Gunpo-Shi, KR). The FDA issued a Cleared decision on May 12, 2016 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Daesung Maref Co., Ltd. devices

FDA 510(k) Submission Details - K150980

510(k) Number K150980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2015
Decision Date May 12, 2016
Days to Decision 394 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 125d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Mtechgroup
DAVE KIM

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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