Cleared Special

K003114 - NUMED TYSHAK AND Z-MED PTV CATHETERS

K003114 is the FDA 510(k) clearance for NUMED TYSHAK AND Z-MED PTV CATHETERS by NuMED, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Special 510(k) pathway after a 27-day FDA review.

K003114 · NuMED, Inc. · Cardiovascular device
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Nov 2000
Decision
27d
Days
Class 2
Risk

K003114 is an FDA 510(k) clearance for the NUMED TYSHAK AND Z-MED PTV CATHETERS. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by NuMED, Inc. (Nicholville, US). The FDA issued a Cleared decision on November 1, 2000 after a review of 27 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 K003114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2000
Decision Date November 01, 2000
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 243
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K003114.
NUMED GHOST II PTA CATHETERS
K003972 · NuMED, Inc. · Jan 2001
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
K003276 · NuMED, Inc. · Dec 2000
NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K003052 · NuMED, Inc. · Nov 2000
CORDIS SLALOM PTA BALLOON CATHETER
K003159 · Cordis Corp. · Oct 2000
TYSHAK, MODEL 102 AND Z-MED, MODEL 302
K991977 · NuMED, Inc. · Sep 2000
GAZELLE BALLOON DILATATION CATHETER
K001134 · Boston Scientific Corp · Aug 2000