MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM

K050456 · Medrad, Inc. · DXT · Jun 17, 2005 · Cardiovascular

Device Facts

• Record ID: K050456
• Device Name: MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Jun 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The MEDRAD Avanta™ Fluid Management Injection System is indicated for the controlled administration of intravascular radio-opaque contrast media and common flushing solutions to humans during angiographic procedures.

Device Story

Avanta Fluid Management Injection System provides controlled delivery of contrast media and flushing solutions during angiography. Device automates fluid administration, replacing manual syringe techniques. Used in clinical settings by medical professionals to enhance imaging procedures. System manages fluid flow rates and volumes, ensuring precise delivery to patient vasculature. Benefits include improved procedural efficiency and consistent contrast delivery.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Angiographic injector system for contrast media and flushing solutions. Classified under 21 CFR 870.1650, Product Code DXT. Operates as a fluid management system for intravascular administration.

Indications for Use

Indicated for controlled administration of intravascular radio-opaque contrast media and common flushing solutions to humans during angiographic procedures.

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 9200 Corporate Boulevard Rockville MD 20850

JUN 177 2005

Medrad, Inc. c/o Mr. Geoff M. Fatzinger Manager Regulatory and Compliance One Medrad Plaza Indianola, PA 15051

K050456 Re:

Avanta Fluid Management Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Injector and Syringe, Angiographic Regulatory Class: II (two) Product Code: 74 DXT Dated: June 8, 2005 Received: June 9, 2005

Dear Mr. Fatzinger:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manatinent date of the Medical Device American For to commerce prior to May 20, 1976, the exactions of the Federal Food. Drug, devices that have been reclassined in assess approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvide of the general controls provisions of the Act. The You may, merclore, manxect the devices, becycler to the general controls provisions of the free 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 If your device is classified (500 above) als. Existing major regulations affecting your device can may be subject to such additional combines, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pourses oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- sissames or our device complies with other requirements of the Act that I DA has made a decemmandis an administered by other Federal agencies. You must or ally rederal statutes and regulations canniness, but not limited to: registration and listing (21 comply with an the Act 31equirements, are and 801); good manufacturing practice requirements as set

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Page 2 - Mr. Geoff M. Fatzinger

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality by tellio (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control providers (Seeting your device as described in your Section 510(k) This letter with anow you to ocgin manisting of substantial equivalence of your device to a legally premits tourneation. The PDF mailing of casification 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 11 you desire specific acries in [phone]. Also, please note the regulation entitled, Comaci the Ories of Comparket 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/industry/support/index.html.

Sincerely yours,

Dina R. de Auner

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): K050456

Device Name: Avanta Fluid Management Injection System

Indications For Use: The MEDRAD Avanta™ Fluid Management Injection System is indicated for the controlled administration of intravascular radio-opaque contrast media and common flushing solutions to humans during angiographic procedures.

Prescription Use × (Part 21 CFR 801 Subpart D) 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)

Duna R. Archer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Koso4 ڪري

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