Cleared Traditional

K150802 - Heavy Double Flexible Tipped Wire Guide

K150802 is the FDA 510(k) clearance for Heavy Double Flexible Tipped Wire Guide by Cook Incorporated. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K150802 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
63d
Days
Class 2
Risk

K150802 is an FDA 510(k) clearance for the Heavy Double Flexible Tipped 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 May 28, 2015 after a review of 63 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Incorporated devices

Submission Details

510(k) Number K150802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2015
Decision Date May 28, 2015
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 381
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K150802.
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
K151840 · Boston Scientific Corporation · Dec 2015
R350 guidewire
K151234 · Vascular Solutions, Inc. · Nov 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
K150445 · Asahi Intecc Co., Ltd. · Jun 2015
Attain Hybrid Guide Wire
K143316 · Medtronic, Inc. · Mar 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
K143587 · Boston Scientific Corporation · Jan 2015
PRELUDE PLASTIC JACKETED GUIDE WIRE
K142051 · Merit Medical Systems, Inc. · Dec 2014