Cleared Special

K003902 - MULTITRACK ANGIOGRAPHIC CATHETER

K003902 is the FDA 510(k) clearance for MULTITRACK ANGIOGRAPHIC CATHETER by NuMED, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Special 510(k) pathway after a 23-day FDA review.

K003902 · NuMED, Inc. · Cardiovascular device
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Jan 2001
Decision
23d
Days
Class 2
Risk

K003902 is an FDA 510(k) clearance for the MULTITRACK ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by NuMED, Inc. (Nicholville, US). The FDA issued a Cleared decision on January 11, 2001 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all NuMED, Inc. devices

Submission Details

510(k) Number K003902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2000
Decision Date January 11, 2001
Days to Decision 23 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 291
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K003902.
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
K011217 · Abbott Laboratories · May 2001
COOK PRESSURE MONITORING CATHETER
K002254 · Cook, Inc. · Mar 2001
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
K003901 · AngioDynamics, Inc. · Jan 2001
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K001578 · AngioDynamics, Inc. · Oct 2000
GOLDEN-RULE SCALING CATHETER
K002416 · Medical Device Technologies, Inc. · Sep 2000
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
K000743 · Boston Scientific Scimed, Inc. · Sep 2000