Cleared Special

K992237 - MEDTRONIC GT2 FUSION GUIDE WIRES

K992237 is the FDA 510(k) clearance for MEDTRONIC GT2 FUSION GUIDE WIRES by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 69-day FDA review.

K992237 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
69d
Days
Class 2
Risk

K992237 is an FDA 510(k) clearance for the MEDTRONIC GT2 FUSION GUIDE WIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on September 9, 1999 after a review of 69 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 Medtronic Vascular devices

Submission Details

510(k) Number K992237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1999
Decision Date September 09, 1999
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
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 500
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K992237.
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
K992169 · Advanced Cardiovascular Systems, Inc. · Oct 1999
.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI
K993257 · Micro Therapeutics, Inc. · Oct 1999
AGILITY STEERABLE GUIDEWIRE
K991646 · Cordis Neurovascular, Inc. · Sep 1999
HI-TORQUE BALANCE TREK GUIDE WIRE
K991152 · Guidant Corp. · Apr 1999
ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.
K990639 · Guidant Corp. · Mar 1999
STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF
K983346 · Guidant Corp. · Mar 1999