Cleared Traditional

K982543 - SILVERSTREAK HYDROPHILIC GUIDEWIRE

K982543 is an FDA 510(k) clearance for SILVERSTREAK HYDROPHILIC GUIDEWIRE, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K982543 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Dec 1998
Decision
143d
Days
Class 2
Risk

K982543 is an FDA 510(k) clearance for the SILVERSTREAK HYDROPHILIC GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (San Clemente, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro Therapeutics, Inc. devices

FDA 510(k) Submission Details - K982543

510(k) Number K982543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1998
Decision Date December 11, 1998
Days to Decision 143 days
Submission Type Traditional
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
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 643
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K982543.
PRESSUREWIRE SENSOR, MODEL #12001
K983506 · Radi Medical Systems AB · Feb 1999
GUIDEWIRE
K982559 · Galt Medical Corp. · Feb 1999
GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018
K982272 · Biotronik, Inc. · Jan 1999
SCIMED INFORMER PRESSURE WIRE SYSTEM
K974241 · Scimed Life Systems, Inc. · Nov 1998
STRATEGY CORONARY WIRE GUIDE
K983771 · Cook, Inc. · Nov 1998
HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282
K982876 · Guidant Corp. · Nov 1998