← Product Code [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC) · K061484

# MODIFICATION TO: SMITHWICK CAROTID SHUNT (K061484)

_Mcpherson Enterprises, Inc. · DXC · Dec 7, 2006 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K061484

## Device Facts

- **Applicant:** Mcpherson Enterprises, Inc.
- **Product Code:** [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC.md)
- **Decision Date:** Dec 7, 2006
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.4450
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Intended Use

The Smithwick Carotid Shunt intended use is for a carotid endanterectomy procedure. The Doppler crystal built into the shunt provides for Audible verification of blood flow during carotid endarterestomy.

## Device Story

Device is a carotid shunt used during carotid endarterectomy; maintains blood flow to brain while artery is clamped. Features integrated Doppler crystal for real-time audible blood flow monitoring. Used in surgical settings by vascular surgeons. Provides continuous feedback on shunt patency; assists surgeon in verifying adequate perfusion; reduces risk of cerebral ischemia during procedure.

## Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

## Technological Characteristics

Device includes an integrated Doppler crystal for flow monitoring. Mechanical shunt design for vascular access. Class II device (21 CFR 870.4450).

## Regulatory Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

## Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 7 2006

McPherson Enterprises, Inc. c/o Mr. William McPherson P.O. Box 270882 Tampa, FL 33688

Re: K061484

Smithwick Carotid Shunt Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (Two) Product Code: DXC Dated: August 7, 2006 Received: August 11, 2006

Dear Mr. McPherson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA access publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. William McPherson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements not Incun or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the est on c product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number: Ko61494

Device Name: Smithwick Doppler and Non-Doppler Carotid Shunt

Indications for Use: The Smithwick Carotid Shunt intended use is for a carotid endanterectomy procedure. The Doppler crystal built into the shunt provides for Audible verification of blood flow during carotid endarterestomy.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K061484

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K061484](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K061484)

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