Cleared Special

K013601 - NUMED MULLINS PTA CATHETER

K013601 is the FDA 510(k) clearance for NUMED MULLINS PTA CATHETER by NuMED, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 64-day FDA review.

K013601 · NuMED, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Jan 2002
Decision
64d
Days
Class 2
Risk

K013601 is an FDA 510(k) clearance for the NUMED MULLINS PTA CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on January 3, 2002 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 K013601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2001
Decision Date January 03, 2002
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 577
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K013601.
AGILTRAC .018 PERIPHERAL DILATATION CATHETER
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K014212 · C.R. Bard, Inc. · Jan 2002
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889 · Boston Scientific Corp · Dec 2001
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
K013638 · Guidant Corp. · Dec 2001
STENT SUPPORT GUIDE CATHETER
K010579 · Medtronic Vascular · Nov 2001