DISPOSABLE 330PSI EXTENSION LINES

K120892 · Coeur, Inc. · DXT · Jun 10, 2013 · Cardiovascular

Device Facts

• Record ID: K120892
• Device Name: DISPOSABLE 330PSI EXTENSION LINES
• Applicant: Coeur, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Jun 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

to be used as an interface between (an) Angiographic, CT, or MR Syringe(s) and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.

Device Story

Disposable 330psi extension lines function as fluid path interfaces between high-pressure syringes (angiographic, CT, or MR) and needle catheters. Used in clinical settings to facilitate delivery of contrast media and saline to patient vascular systems. Device ensures secure, pressure-rated connection for diagnostic imaging procedures. Operated by clinicians during imaging workflows.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable extension lines rated for 330psi; designed for high-pressure fluid path connectivity between syringes and catheters.

Indications for Use

Indicated for use as an interface between angiographic, CT, or MR syringes and needle catheters to deliver diagnostic fluids (contrast media and saline) to the vascular system.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 10, 2013

Coeur, Inc. Ms. Debra Manning Director, Quality & Regulatory Affairs 100 Physicians Wav. Suite 200 Lebanon, TN 37090

Re: K120892

Trade/Device Name: Disposable 330psi Extension Lines Regulation Number: 21 CFR 870.1650 Regulation Name: Injector and Syringe, Angiographic Regulatory Class: Class II Product Code: DXT · Dated: May 24, 2013 Received: May 28, 2013

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 general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If vour 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/Resourcesfor You/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,

Matthew G. Hillebrenner

for Bram D. Zuckerman, M.D.
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

K120892 510(k) Number (if known):

Device Name: Coeur, Inc. Disposable, 330psi Extension Lines

Indications For Use:

to be used as an interface between (an) Angiographic, CT, or MR Syringe(s) and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.

Prescription Use V (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)

## Matthew GJ视ebrenner

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