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FDA 510(k)

SMITHWICK CAROTID SHUNT

K-Number: K062474 · 2006-11-09

ApplicantMcpherson Enterprises, Inc.
Decision Date2006-11-09
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMITHWICK CAROTID SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Mcpherson Enterprises, Inc.. It received FDA 510(k) clearance on 2006-11-09 under 510(k) number K062474. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITHWICK CAROTID SHUNT?

SMITHWICK CAROTID SHUNT is a medical device that received FDA 510(k) clearance on 2006-11-09. The listed applicant is Mcpherson Enterprises, Inc.. The 510(k) number is K062474.

When did SMITHWICK CAROTID SHUNT receive FDA 510(k) clearance?

SMITHWICK CAROTID SHUNT received FDA 510(k) clearance on 2006-11-09, under 510(k) number K062474.

Who is the listed applicant for SMITHWICK CAROTID SHUNT?

The FDA 510(k) record lists Mcpherson Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMITHWICK CAROTID SHUNT?

The FDA product code for SMITHWICK CAROTID SHUNT is DXC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Mcpherson Enterprises, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061484MODIFICATION TO: SMITHWICK CAROTID SHUNTK823565MULTI-LUMEN INTRAVENOUS CATHETER

Related Devices (Code: DXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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