THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003

K032920 · Coeur Medical · DXT · Dec 16, 2003 · Cardiovascular

Device Facts

• Record ID: K032920
• Device Name: THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003
• Applicant: Coeur Medical
• Product Code: DXT · Cardiovascular
• Decision Date: Dec 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Coeur Injector Adaptor / Pressure Jacket is intended to be installed on Liebel-Flarsheim Angiomat 6000 and Angiomat Illumena Contrast Delivery Systems to allow the injectors to be used with the Coeur 150mL A-Series (Angiographic and CT) Syringes (Catalog Numbers: C853-6150 and C853-6159).

Device Story

The Coeur Injector Adaptor/Pressure Jacket is a mechanical accessory designed for integration with Liebel-Flarsheim Angiomat 6000 and Angiomat Illumena contrast delivery systems. It functions as a physical interface, allowing these specific injector systems to accommodate Coeur 150mL A-Series syringes. The device is used in clinical settings where contrast media delivery is required for angiographic or CT procedures. It is operated by trained healthcare professionals, such as radiology technicians or nurses, as part of the standard contrast injection workflow. By enabling the use of Coeur-branded syringes with existing injector hardware, the device provides compatibility, allowing clinicians to maintain established contrast delivery protocols while utilizing Coeur's syringe products.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical adaptor/pressure jacket. Designed for physical compatibility with Liebel-Flarsheim Angiomat 6000 and Angiomat Illumena injector systems. No electronic components, software, or energy sources.

Indications for Use

Indicated for use with Liebel-Flarsheim Angiomat 6000 and Angiomat Illumena Contrast Delivery Systems to facilitate the use of Coeur 150mL A-Series syringes for angiographic and CT contrast delivery.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Reference Devices

• Liebel-Flarsheim Angiomat 6000
• Liebel-Flarsheim Angiomat Illumena

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to promote health, well-being, and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2003

COEUR Medical A Division of COEUR, Inc. c/o Ms. Debra F. Manning VP, Quality & Regulatory Affairs 209 Creekside Drive P.O. Box 2125 Washington, NC 27889

K032920 Re:

> The COEUR Injector Adaptor/Pressure Jacket, Model C859-6003 Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: September 15, 2003 Received: September 22, 2003

Dear Ms. Manning:

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 Codc 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

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Page 2 -- Ms. Debra F. Manning

comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Her orean enterested (1); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quand of ovisions (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) This lotter will and in you to ough finding of substantial equivalence of your device to a legally premated notificate 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 [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 Manufacturers, 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 yours,

Quse D, Hary Jr

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): K032920

Device Name: Coeur Medical, a division of Cocur, Inc., Injector Adapter / Pressure Jacket

Indications For Use:

The Coeur Injector Adaptor / Pressure Jacket is intended to be installed on Liebel-Flarsheim Angiomal* 6000 and Angiomat* Illumena** Contrast Delivery Systems to allow the injectors to be used with the Coeur 150mL A-Series (Angiographic andCT) Syringes (Catalog Numbers: C853-6150 and C853-6159).

V Prescription Use (Part 21 CFR 801 Subpart D)

-10(K) Number

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kisond. Htz. C. Bramzaden

(Division Sign-off)
Division of Cardiovascular Devices

12/16/03

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