Cleared Traditional

NOVA BALLOON THERMODILUTION INFUSION (K841640) - FDA 510(k) Clearance

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

K841640 · Nova Medical Specialties · Cardiovascular device
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Aug 1984
Decision
114d
Days
Class 2
Risk

K841640 is an FDA 510(k) clearance for the NOVA BALLOON THERMODILUTION INFUSION. 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 August 12, 1984 after a review of 114 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Nova Medical Specialties devices

Submission Details

510(k) Number K841640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1984
Decision Date August 12, 1984
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 125d · This submission: 114d
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 K841640.
BARD-PARKER OCCLUSION BALLOON CATHETER
K852294 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985
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