Cleared Traditional

K093515 - 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON

K093515 is an FDA 510(k) clearance for 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG ..., manufactured by Brivant, Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K093515 · Brivant, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
95d
Days
Class 2
Risk

K093515 is an FDA 510(k) clearance for the 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT .... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Brivant, Ltd. (Galway, IE). The FDA issued a Cleared decision on February 16, 2010 after a review of 95 days - within the typical 510(k) review window.

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 Brivant, Ltd. devices

FDA 510(k) Submission Details - K093515

510(k) Number K093515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2009
Decision Date February 16, 2010
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
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 616
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K093515.
NEUROSCOUT STEERABLE GUIDEWIRE
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TRAILRUNNER GUIDEWIRES
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TRAXCESS DOCKING WIRE
K093647 · MicroVention, Inc. · Feb 2010
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
K093397 · MicroVention, Inc. · Dec 2009
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
K091582 · Medtronic Vascular · Dec 2009
MERIT LAUREATE HYDROPHILIC GUIDE WIRE
K092303 · Merit Medical Systems, Inc. · Oct 2009