Cleared Traditional

K171445 - Amplatz Support Wire Guide with Apex Curve

K171445 is an FDA 510(k) clearance for Amplatz Support Wire Guide with Apex Curve, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K171445 · Cook Incorporated · Cardiovascular device
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Jan 2018
Decision
239d
Days
Class 2
Risk

K171445 is an FDA 510(k) clearance for the Amplatz Support Wire Guide with Apex Curve. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on January 10, 2018 after a review of 239 days - an extended review cycle.

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 Cook Incorporated devices

FDA 510(k) Submission Details - K171445

510(k) Number K171445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2017
Decision Date January 10, 2018
Days to Decision 239 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
114d slower than avg
Panel avg: 125d · This submission: 239d
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 581
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K171445.
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
K171933 · Asahi Intecc Co., Ltd. · Feb 2018
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile
K173235 · Scientia Vascular, LLC · Jan 2018
HI-TORQUE TurnTrac Guide Wire Family
K173795 · Abbott Vascular · Jan 2018
Roadrunner Extra Support Wire Guide
K171948 · Cook Incorporated · Jan 2018
Raider Guidewire
K173532 · Vascular Solutions, Inc. · Dec 2017
WATCHDOG Hemostasis Valve Kit
K172453 · Boston Scientific Corporation · Nov 2017