Cleared Traditional

K940264 - VASOGENICS EECP-MC2

K940264 is an FDA 510(k) clearance for VASOGENICS EECP-MC2, manufactured by Vasogenics, Inc.. The device is a Class 2 Cardiovascular device with product code DRN cleared through the Traditional 510(k) pathway after a 398-day FDA review.

K940264 · Vasogenics, Inc. · Cardiovascular device
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Feb 1995
Decision
398d
Days
Class 2
Risk

K940264 is an FDA 510(k) clearance for the VASOGENICS EECP-MC2. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Vasogenics, Inc. (Port Jefferson Station, US). The FDA issued a Cleared decision on February 23, 1995 after a review of 398 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5225 - 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 Vasogenics, Inc. devices

FDA 510(k) Submission Details - K940264

510(k) Number K940264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date February 23, 1995
Days to Decision 398 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 125d · This submission: 398d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRN Device Classification - Class 2, Special Controls

Product Code DRN Device, Counter-pulsating, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5225
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.