Cleared Traditional

K991646 - AGILITY STEERABLE GUIDEWIRE

K991646 is an FDA 510(k) clearance for AGILITY STEERABLE GUIDEWIRE, manufactured by Cordis Neurovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K991646 · Cordis Neurovascular, Inc. · Cardiovascular device
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Sep 1999
Decision
133d
Days
Class 2
Risk

K991646 is an FDA 510(k) clearance for the AGILITY STEERABLE GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lake, US). The FDA issued a Cleared decision on September 23, 1999 after a review of 133 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 Cordis Neurovascular, Inc. devices

FDA 510(k) Submission Details - K991646

510(k) Number K991646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1999
Decision Date September 23, 1999
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
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 677
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K991646.
BARD HYDROPHILIC COATED GUIDE WIRES
K993000 · C.R. Bard, Inc. · Nov 1999
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
MEDTRONIC GT2 FUSION GUIDE WIRES
K992237 · Medtronic Vascular · Sep 1999
ENDOSONICS TRAK BACK DEVICE
K990271 · Endosonics Corp. · Aug 1999
PVS 1400 GUIDEWIRE
K990823 · Precision Vascular Systems, Inc. · Jul 1999