Cleared Traditional

K830150 - VEINPREP VEIN GRAFT PREP. KIT A277723

K830150 is an FDA 510(k) clearance for VEINPREP VEIN GRAFT PREP. KIT A277723, manufactured by Atrium Medical Corp.. The device is a Class 2 Cardiovascular device with product code DWD cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K830150 · Atrium Medical Corp. · Cardiovascular device
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Feb 1983
Decision
42d
Days
Class 2
Risk

K830150 is an FDA 510(k) clearance for the VEINPREP VEIN GRAFT PREP. KIT A277723. Classified as Suction Control, Intracardiac, Cardiopulmonary Bypass (product code DWD), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1983 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4430 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Atrium Medical Corp. devices

FDA 510(k) Submission Details - K830150

510(k) Number K830150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1983
Decision Date February 28, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWD Device Classification - Class 2, Special Controls

Product Code DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4430
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 - DWD Suction Control, Intracardiac, Cardiopulmonary Bypass

All 8
Devices cleared under the same product code (DWD) and FDA review panel - the closest regulatory comparables to K830150.
SARNS SAFETY LOOP
K863593 · 3M Health Care, Sarns · Nov 1986
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
K862540 · Gish Biomedical, Inc. · Aug 1986
IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-
K830149 · Instrumentation Laboratory CO · Feb 1983
VACUUM RELIEF VALVE
K760894 · Delta Medical Industries · Dec 1976