OCCLUSION PERFUSION CATHETER

K130525 · Advanced Catheter Therapies, Inc. · DQY · Oct 3, 2013 · Cardiovascular

Device Facts

• Record ID: K130525
• Device Name: OCCLUSION PERFUSION CATHETER
• Applicant: Advanced Catheter Therapies, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Occlusion Perfusion Catheter 10 is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.

Device Story

Occlusion Perfusion Catheter is a percutaneous catheter designed for localized delivery of diagnostic or therapeutic agents into peripheral vasculature. Device facilitates targeted infusion or irrigation; enables localized treatment while minimizing systemic exposure. Used by clinicians in clinical settings. Operates via standard percutaneous catheterization techniques. Benefits include precise agent delivery to specific peripheral vascular sites.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous catheter; Class II device (21 CFR 870.1250); Product Code DQY. Mechanical infusion/irrigation delivery system.

Indications for Use

Indicated for localized infusion or irrigation of diagnostic and therapeutic agents into the peripheral vasculature. Contraindicated for use in the neurovasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

October 3, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Ci609 Silver Spring, MD 20993-0002

Advanced Catheter Therapies, Inc. c/o Ms. Christina Henza Regulatory Affairs Specialist Regulatory Compliance Associates, Inc. 10411 Corporate Drive Suite 102 Pleasant Prairie, WI 53158

Re: K130525

Trade/Device Name: Occlusion Perfusion Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 9, 2013 Received: September 11, 2013

Dear Ms. Henza:

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 10 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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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, FDA 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); medical device reporting (reporting of medical

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Page 2 - Ms. Christina Henza

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Bram D. Zuckerman -S

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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## Indications for Use

510(k) Number (if known):

Device Name: Occlusion Perfusion CatheterTM

Indications For Use:

The Occlusion Perfusion Catheter 10 is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bram D. Zuckerman -S 2013.10.03 15:44:03 -04'00'

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