Cleared Traditional

CARDIOVASCULAR DISPOSABLE PRODUCTS (K830728) - FDA 510(k) Clearance

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

K830728 · Electromics, Inc. · Cardiovascular device
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Apr 1983
Decision
51d
Days
Class 2
Risk

K830728 is an FDA 510(k) clearance for the CARDIOVASCULAR DISPOSABLE PRODUCTS. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Electromics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Electromics, Inc. devices

Submission Details

510(k) Number K830728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1983
Decision Date April 28, 1983
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 122
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K830728.
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ARGYLE CAROTID ARTERY LOOP SHUNT
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K791947 · Shiley, Inc. · Nov 1979