Cleared Traditional

K830150 - VEINPREP VEIN GRAFT PREP. KIT A277723 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830150 · Atrium Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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.