Cleared Traditional

ROLL-X GUIDEWIRE (K082304) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082304 · St Jude Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2008
Decision
14d
Days
Class 2
Risk

K082304 is an FDA 510(k) clearance for the ROLL-X GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on August 27, 2008 after a review of 14 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 St Jude Medical devices

Submission Details

510(k) Number K082304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2008
Decision Date August 27, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 223
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K082304.
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
K091385 · Cook, Inc. · Aug 2009
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
K090554 · Boston Scientific Corp · Jul 2009
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
K082873 · Medtronic Vascular · Feb 2009
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021 · Boston Scientific Corp · Aug 2008
APPROACH CTO WIRE GUIDE
K081337 · Cook Incorporated · Aug 2008
MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
K072552 · Merit Medical Systems, Inc. · Dec 2007