Cleared Traditional

K180830 - Reuter Tip Deflecting Wire Guide

K180830 is an FDA 510(k) clearance for Reuter Tip Deflecting 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 265-day FDA review.

K180830 · Cook Incorporated · Cardiovascular device
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Dec 2018
Decision
265d
Days
Class 2
Risk

K180830 is an FDA 510(k) clearance for the Reuter Tip Deflecting 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 December 20, 2018 after a review of 265 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 - K180830

510(k) Number K180830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2018
Decision Date December 20, 2018
Days to Decision 265 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
140d slower than avg
Panel avg: 125d · This submission: 265d
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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K180830.
Inno-Pathwire
K182553 · Suzhou Innomed Medical Device Co., Ltd. · Mar 2019
Lunderquist® Fixed Core Wire Guide
K181353 · Cook Incorporated · Feb 2019
Roadrunner Extra Support Wire Guide
K183467 · Cook Incorporated · Jan 2019
Magic Torque DLVR Guidewire
K182315 · Boston Scientific Corporation · Sep 2018
Bandit guidewire
K181647 · Vascular Solutions, Inc. · Jul 2018
ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES
K180784 · Asahi Intecc Co., Ltd. · Jul 2018