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
Download Printable Device Report (PDF)
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
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 Peers - JOW Sleeve, Limb, Compressible

All 123
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K150980.
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