Cleared Special

MODIFICATION TO: SMITHWICK CAROTID SHUNT (K061484) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K061484 · Mcpherson Enterprises, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
191d
Days
Class 2
Risk

K061484 is an FDA 510(k) clearance for the MODIFICATION TO: SMITHWICK CAROTID SHUNT. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Mcpherson Enterprises, Inc. (Tampa, US). The FDA issued a Cleared decision on December 7, 2006 after a review of 191 days - an extended review cycle.

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

View all Mcpherson Enterprises, Inc. devices

Submission Details

510(k) Number K061484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2006
Decision Date December 07, 2006
Days to Decision 191 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 125d · This submission: 191d
Pathway characteristics
Modification to existing cleared device.

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 203
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K061484.
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
K260105 · Edwards Lifesciences · Jun 2026
Arc Adjustable Radial Cuff Compression Device
K252772 · Tz Medical, Inc. · May 2026
Life Saving Tourniquet
K254060 · TW Medical · Apr 2026
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC)
K243627 · Arc Trauma, LLC · Dec 2025
Namic Radial Arm Band, 23 cm (DYNJRADBAND)
K253070 · Medline Industries, LP · Nov 2025
Radial Compression Device
K232577 · Ningbo Dizegens Medical Science Co.,Ltd · Jan 2024