Cleared Special

K100351 - NEUROSCOUT STEERABLE GUIDEWIRE

K100351 is the FDA 510(k) clearance for NEUROSCOUT STEERABLE GUIDEWIRE by Codman & Shurtleff, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 32-day FDA review.

K100351 · Codman & Shurtleff, Inc. · Cardiovascular device
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Mar 2010
Decision
32d
Days
Class 2
Risk

K100351 is an FDA 510(k) clearance for the NEUROSCOUT STEERABLE GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on March 16, 2010 after a review of 32 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K100351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date March 16, 2010
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

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 443
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K100351.
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
K100930 · Volcano Corporation · Apr 2010
ROLL-X GUIDEWIRE
K100710 · St Jude Medical · Apr 2010
GTX 12 GIDEWIRE
K100470 · Medtronic, Inc. · Apr 2010
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