TAKA ANEURYSM CLIP

K972750 · V. Mueller Neuro/Spine · HCH · Jul 9, 1998 · Neurology

Device Facts

• Record ID: K972750
• Device Name: TAKA ANEURYSM CLIP
• Applicant: V. Mueller Neuro/Spine
• Product Code: HCH · Neurology
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Temporary occlusion of intracranial blood verssels/aneurysms. Permanent placement in the brain for occlusion of aneurysms.

Device Story

Taka Aneurysm Clip is a surgical implant used for the occlusion of intracranial aneurysms. The device is intended for both temporary occlusion during surgical procedures and permanent implantation to secure aneurysms. It is used by neurosurgeons in an operating room setting. The clip functions by providing mechanical compression to the blood vessel wall to stop or prevent blood flow into an aneurysm, thereby reducing the risk of rupture. The device is placed surgically; the surgeon uses specialized instrumentation to apply the clip to the neck of the aneurysm. By isolating the aneurysm from the parent vessel, the device helps prevent hemorrhage and potential neurological damage. The clip remains in the patient's brain permanently unless removed or adjusted during subsequent surgical intervention.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Aneurysm clip for intracranial use. Mechanical device; no energy source or software. Materials and dimensions are consistent with standard surgical aneurysm clips classified under 21 CFR 882.5200.

Indications for Use

Indicated for temporary occlusion of intracranial blood vessels/aneurysms and permanent placement in the brain for occlusion of aneurysms.

Regulatory Classification

Identification

An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.

Submission Summary (Full Text)

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NOV 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pacific Surgical Innovations, Inc. % Mr. Terry Johnston President 360 Industrial Road, Unit H San Carlos, California 94070

Re: K972750

Trade/Device Name: Taka Aneurysm Clip Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm clip Regulatory Class: II Product Code: HCH, HCI Dated: June 8, 1998 Received: June 15, 1998

Dear Mr. Johnston:

This letter corrects our substantially equivalent letter of July 9, 1998.

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 fo devices that have been reclassified in accordance with the provisions of the Federal Foend. Orug and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). 701 may, therefore, market the device, subject to the general controls provisions of the Act. The goneral 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 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, PTDA may publish further announcements concerning your device in the Federal Register.

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 of the Act 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 eestronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000- 050.

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Page 2 - Mr. Terry Johnston

This letter will allow you to continue marketing your device as described in your Section 510(k) I mis lotter will anon yourse FDA finding of substantial equivalence of your device to a legally premailer notificated on " 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 if you doon o office of Compliance at [phone]. 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 other general International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely you

for Pts. Thoms Das Dastgul

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972750

## SECTION 5

## INDICATIONS FOR USE

510(K) Number:

K972750

Device Name:

Taka (Tm) Aneurysm Clip

Indications for Use:

Temporary occlusion of intracranial blood verssels/aneurysms.

Permanent placement in the brain for occlusion of aneurysms.

rdiovascular, Respiratory, rological Devices 972750

**Prescription Use**

OR

Over the Counter _____________________________________________________________________________________________________________________________________________________________