Cleared Special

K001454 - SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D

K001454 is an FDA 510(k) clearance for SILVERSPEED HYDROPHILIC GUIDEWIRE (0.01..., manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 29-day FDA review.

K001454 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
29d
Days
Class 2
Risk

K001454 is an FDA 510(k) clearance for the SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SIL.... 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 June 7, 2000 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.

FDA 510(k) Submission Details - K001454

510(k) Number K001454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2000
Decision Date June 07, 2000
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 762
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K001454.
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
K002212 · Micro Therapeutics, Inc. · Aug 2000
GALEO HYDRO AND GALEO HYDRO J-TIP
K001736 · Biotronik, Inc. · Aug 2000
SNIPER, MODEL OR-3872XX SERIES
K001251 · Nipro Medical Corp. · Jul 2000
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
K001198 · Datascope Corp. · May 2000
AGILITY STEERABLE GUIDEWIRE
K001033 · Cordis Neurovascular, Inc. · Apr 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE
K000011 · Lake Region Mfg., Inc. · Mar 2000
K001454 · SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
Download PDF FDA Summary Micro Therapeutics, I…