Cleared Traditional

K963336 - HARMAC THERMODILUTION CATHETER

K963336 is an FDA 510(k) clearance for HARMAC THERMODILUTION CATHETER, manufactured by Harmac Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 412-day FDA review.

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

FDA 510(k) Submission Details - K963336

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
Combination Product No
PCCP Authorized No
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.

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 69
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K963336.
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K955816 · Baxter Healthcare Corp · May 1997
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K963248 · J-Lloyd Medical, Inc. · Feb 1997
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K961999 · Boston Scientific Scimed, Inc. · Nov 1996