Cleared Special

K103377 - CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283

K103377 is an FDA 510(k) clearance for CHARTER GUIDEWIRE MODEL 45-281, 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 182-day FDA review.

K103377 · Brivant, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
182d
Days
Class 2
Risk

K103377 is an FDA 510(k) clearance for the CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283. 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 May 18, 2011 after a review of 182 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K103377

510(k) Number K103377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2010
Decision Date May 18, 2011
Days to Decision 182 days
Submission Type Special
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
57d slower than avg
Panel avg: 125d · This submission: 182d
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 742
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K103377.
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
K111485 · Boston Scientific Corporation · Jun 2011
MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
K111488 · Bridgepoint Medical · Jun 2011
FATHOM (TM) 14 STEERABLE GUIDEWIRE
K111498 · Boston Scientific Corp · Jun 2011
ACUITY WHISPER VIEW GUIDE WIRES
K110479 · Boston Scientific Corp · Apr 2011
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
K110553 · Asahi Intecc USA, Inc. · Mar 2011
ASAHI GUIDE WIRE EXTENSION 165CM
K101985 · Asahi Intecc Co., Ltd. · Mar 2011
K103377 · CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
Download PDF FDA Summary Brivant, Ltd.