Cleared Special

K003643 - NUMED Z-MED PTV CATHERERS

K003643 is an FDA 510(k) clearance for NUMED Z-MED PTV CATHERERS, manufactured by NuMED, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 30-day FDA review.

K003643 · NuMED, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
30d
Days
Class 2
Risk

K003643 is an FDA 510(k) clearance for the NUMED Z-MED PTV CATHERERS. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on December 27, 2000 after a review of 30 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.

FDA 510(k) Submission Details - K003643

510(k) Number K003643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2000
Decision Date December 27, 2000
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

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 895
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K003643.
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K010169 · C.R. Bard, Inc. · Feb 2001
ANCURE LLIAC BALLOON CATHETER
K003495 · Guidant Cardiac and Vascular Surgery · Feb 2001
OUTBACK CATHETER
K001577 · Lumend, Inc. · Jan 2001
ILT 0.014 CATHETER, MODEL C114NL2
K001992 · Intra Luminal Therapeutics, Inc. · Sep 2000
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
K001969 · Medtronic Vascular · Aug 2000
VIKING OPTIMA GUIDING CATHETER
K001435 · Guidant Corp. · Jun 2000
K003643 · NUMED Z-MED PTV CATHERERS
Download PDF FDA Summary NuMED, Inc.