Cleared Traditional

K841639 - NOVA BALLOON THERMODILUTION CATH.

K841639 is an FDA 510(k) clearance for NOVA BALLOON THERMODILUTION CATH., manufactured by Nova Medical Specialties. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K841639 · Nova Medical Specialties · Cardiovascular device
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Aug 1984
Decision
114d
Days
Class 2
Risk

K841639 is an FDA 510(k) clearance for the NOVA BALLOON THERMODILUTION CATH.. 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

FDA 510(k) Submission Details - K841639

510(k) Number K841639 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.

DYG Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K841639.
MEDTRONIC MODEL 6404
K851948 · Medtronic Vascular · Jun 1985
FLOW-DIRECTED THERMODILUTION CATH
K843409 · Andover Medical, Inc. · Oct 1984
THERMAL DILUTION CATHETER
K843411 · Andover Medical, Inc. · Oct 1984
DESERET HEPARIN COATED FLOW CATH
K841251 · Parke-Davis Co. · Jun 1984
DESERET HEPARIN COATED FLOW DIRECTED
K841317 · Parke-Davis Co. · Jun 1984
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836 · Instrumentation Laboratory CO · Feb 1984