Cleared Special

K030549 - HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG

K030549 is an FDA 510(k) clearance for HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDR..., manufactured by Guidcorp. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 82-day FDA review.

K030549 · Guidcorp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
82d
Days
Class 2
Risk

K030549 is an FDA 510(k) clearance for the HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE P.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Guidcorp (Temecula, US). The FDA issued a Cleared decision on May 14, 2003 after a review of 82 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 Guidcorp devices

FDA 510(k) Submission Details - K030549

510(k) Number K030549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2003
Decision Date May 14, 2003
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Modification to existing cleared device.

DQX Device Classification - Class 2, Special Controls

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 671
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K030549.
PERIVAC KIT
K032050 · Boston Scientific Corp · Aug 2003
IQ HYDROPHILIC GUIDE WIRE
K032183 · Boston Scientific Corp · Aug 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · Boston Scientific Scimed, Inc. · May 2003
STEERABLE GUIDEWIRE
K022813 · Lake Region Mfg., Inc. · Feb 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019 · Guidant Corp. · Jan 2003
ENDOVASCULAR GUIDE WIRE
K021363 · Stereotaxis, Inc. · Nov 2002