Cleared Traditional

HARMAC BALLOON WEDGE PRESSURE CATHETER (K963335) - FDA 510(k) Clearance

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

K963335 · Harmac Medical Products, Inc. · Cardiovascular device
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Oct 1997
Decision
475d
Days
Class 2
Risk

K963335 is an FDA 510(k) clearance for the HARMAC BALLOON WEDGE PRESSURE CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Harmac Medical Products, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 16, 1997 after a review of 475 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 K963335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1996
Decision Date October 16, 1997
Days to Decision 475 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
350d slower than avg
Panel avg: 125d · This submission: 475d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 143
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K963335.
ENVY GUIDING CATHETER
K974774 · Cook, Inc. · Oct 1998
SITESEER ANGIOGRAPHIC CATHETER
K980575 · C.R. Bard, Inc. · May 1998
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
K973401 · Cordis Corp. · Nov 1997
MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS
K965112 · Medline Industries, Inc. · Oct 1997
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER
K970854 · Cordis Corp. · Sep 1997
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
K970207 · Boston Scientific Corp · Jul 1997