Cleared Special

K102211 - CRUISER 18 GUIDEWIRE

K102211 is an FDA 510(k) clearance for CRUISER 18 GUIDEWIRE, manufactured by Brivant, Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 29-day FDA review.

K102211 · Brivant, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
29d
Days
Class 2
Risk

K102211 is an FDA 510(k) clearance for the CRUISER 18 GUIDEWIRE. 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 September 3, 2010 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Brivant, Ltd. devices

FDA 510(k) Submission Details - K102211

510(k) Number K102211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2010
Decision Date September 03, 2010
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K102211.
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
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NEOWIRE PTA/PTCA GUIDEWIRE
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K100578 · Asahi Intecc Co., Ltd. · Sep 2010
ARCHER SUPER STIFF GUIDEWIRES
K101339 · Medtronic, Inc. · Aug 2010
HI-TORQUE WINN GUIDE WIRE FAMILY
K101648 · Abbott Vascular, Inc. · Jul 2010
HASKAL TORQUE DEVICE
K100425 · Elcam Medical Acal · Jun 2010