Cleared Traditional

K171997 - Mandril Wire Guide

K171997 is an FDA 510(k) clearance for Mandril Wire Guide, 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 270-day FDA review.

K171997 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
270d
Days
Class 2
Risk

K171997 is an FDA 510(k) clearance for the Mandril Wire Guide. 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 March 30, 2018 after a review of 270 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 - K171997

510(k) Number K171997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2017
Decision Date March 30, 2018
Days to Decision 270 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
145d slower than avg
Panel avg: 125d · This submission: 270d
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 K171997.
Medtronic Confida Brecker Guidewire
K181001 · Medtronic Core Valve, LLC · May 2018
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
K180795 · Boston Scientific · Apr 2018
Inno-Hydrowire
K172187 · Suzhou Innomed Medical Device Co., Ltd. · Apr 2018
Double Flexible Tip Wire Guides
K171912 · Cook Incorporated · Mar 2018
Fixed Core Wire Guides
K171764 · Cook Incorporated · Mar 2018
Warrior 14 guidewire
K180128 · Vascular Solutions, Inc. · Feb 2018