Cleared Traditional

HARMAC THERMODILUTION CATHETER (K963336) - FDA 510(k) Clearance

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

K963336 · Harmac Medical Products, Inc. · Cardiovascular device
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Aug 1997
Decision
412d
Days
Class 2
Risk

K963336 is an FDA 510(k) clearance for the HARMAC THERMODILUTION CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Harmac Medical Products, Inc. (Buffalo, US). The FDA issued a Cleared decision on August 14, 1997 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Harmac Medical Products, Inc. devices

Submission Details

510(k) Number K963336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1996
Decision Date August 14, 1997
Days to Decision 412 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
287d slower than avg
Panel avg: 125d · This submission: 412d
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 30
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K963336.
Swan-Ganz Catheters
K193466 · Edwards Lifesciences, LLC · Feb 2020
ATTAIN 6215 VENOGRAM BALLOON CATHETER
K012225 · Medtronic Vascular · Aug 2001
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
K001063 · Baxter Healthcare Corp · Jul 2000
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
K955816 · Baxter Healthcare Corp · May 1997
SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]
K951566 · Baxter Healthcare Corp · Nov 1995
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
K934742 · Baxter Healthcare Corp · Jan 1994