Cleared Traditional

K062474 - SMITHWICK CAROTID SHUNT

K062474 is the FDA 510(k) clearance for SMITHWICK CAROTID SHUNT by Mcpherson Enterprises, Inc.. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K062474 · Mcpherson Enterprises, Inc. · Cardiovascular device
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Nov 2006
Decision
77d
Days
Class 2
Risk

K062474 is an FDA 510(k) clearance for the SMITHWICK CAROTID SHUNT. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Mcpherson Enterprises, Inc. (Pinellas Park, US). The FDA issued a Cleared decision on November 9, 2006 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Mcpherson Enterprises, Inc. devices

Submission Details

510(k) Number K062474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2006
Decision Date November 09, 2006
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 65
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K062474.
TR BAND
K070423 · Terumo Medical Corp. · Mar 2007
D-STAT HANDLE, MODEL 8500-053
K063871 · Vascular Solutions, Inc. · Feb 2007
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
K062569 · Datascope Corp. · Feb 2007
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
K050146 · Vascular Solutions, Inc. · May 2005
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040730 · Vascular Solutions, Inc. · Jun 2004
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K014277 · KARL STORZ Endoscopy-America, Inc. · Dec 2002