Cleared Traditional

HEPARIN COATED BALLOON THERMODILU (K834037) - FDA 510(k) Clearance

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

K834037 · Nova Medical Specialties · Cardiovascular device
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Jan 1984
Decision
48d
Days
Class 2
Risk

K834037 is an FDA 510(k) clearance for the HEPARIN COATED BALLOON THERMODILU. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Nova Medical Specialties (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Nova Medical Specialties devices

Submission Details

510(k) Number K834037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1983
Decision Date January 10, 1984
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 31
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K834037.
BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI
K850952 · C.R. Bard, Inc. · Aug 1985
MEDTRONIC MODEL 6404
K851948 · Medtronic Vascular · Jun 1985
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836 · Instrumentation Laboratory CO · Feb 1984
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854 · C.R. Bard, Inc. · Oct 1983
CARDIAC OUTPUT MEASURE SYSTEM
K831185 · Cook, Inc. · May 1983
THERMAL DILUTION CATHETER
K823484 · Instrumentation Laboratory CO · Dec 1982