Cleared Special

K041306 - NUMED PTS X SIZING BALLOON CATHETER

K041306 is the FDA 510(k) clearance for NUMED PTS X SIZING BALLOON CATHETER by NuMED, Inc.. It is a Class 2 Cardiovascular device (product code MJN) cleared through the Special 510(k) pathway after a 24-day FDA review.

K041306 · NuMED, Inc. · Cardiovascular device
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Jun 2004
Decision
24d
Days
Class 2
Risk

K041306 is an FDA 510(k) clearance for the NUMED PTS X SIZING BALLOON CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on June 10, 2004 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 K041306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2004
Decision Date June 10, 2004
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 45
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K041306.
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
K081454 · Possis Medical, Inc. · Jun 2008
GORE BALLOON SHEATH
K070770 · W.L. Gore & Associates, Inc. · Jun 2007
MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
K062220 · Possis Medical, Inc. · Aug 2006
GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM
K031357 · Possis Medical, Inc. · May 2004
MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
K021066 · Micro Therapeutics, Inc. · Jun 2002
CADENCE PRECISION INJECTOR, MODEL 103-0304
K011535 · Micro Therapeutics, Inc. · Aug 2001