Cleared Special

K010497 - SILVERSPEED HYDROPHILIC GUIDEWIRE

K010497 is the FDA 510(k) clearance for SILVERSPEED HYDROPHILIC GUIDEWIRE by Micro Therapeutics, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 29-day FDA review.

K010497 · Micro Therapeutics, Inc. · Cardiovascular device
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Mar 2001
Decision
29d
Days
Class 2
Risk

K010497 is an FDA 510(k) clearance for the SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Irvine, US). The FDA issued a Cleared decision on March 22, 2001 after a review of 29 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 Micro Therapeutics, Inc. devices

Submission Details

510(k) Number K010497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2001
Decision Date March 22, 2001
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 445
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K010497.
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096
K013833 · Guidant Corp. · Jan 2002
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K013092 · Guidant Corp. · Dec 2001
BACK-UP MEIER GUIDEWIRE
K011906 · Boston Scientific Corp · Aug 2001
INQWIRE DIAGNOSTIC GUIDE WIRE
K002289 · Merit Medical Systems, Inc. · Oct 2000
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
K002206 · Guidant Corp. · Aug 2000
GALEO HYDRO AND GALEO HYDRO J-TIP
K001736 · Biotronik, Inc. · Aug 2000