Cleared Special

HYDROPHILIC GUIDEWIRE (K033758) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033758 · Lake Region Mfg., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
17d
Days
Class 2
Risk

K033758 is an FDA 510(k) clearance for the HYDROPHILIC GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Lake Region Mfg., Inc. devices

Submission Details

510(k) Number K033758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2003
Decision Date December 19, 2003
Days to Decision 17 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 252
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K033758.
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
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IQ GUIDE WIRE
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K033742 · Boston Scientific Corp · Jan 2004
PERIVAC KIT
K032050 · Boston Scientific Corp · Aug 2003
IQ HYDROPHILIC GUIDE WIRE
K032183 · Boston Scientific Corp · Aug 2003
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283 · Boston Scientific Corp · Feb 2002