ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER

K061733 · AngioDynamics, Inc. · DQO · Aug 24, 2006 · Cardiovascular

Device Facts

• Record ID: K061733
• Device Name: ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
• Applicant: AngioDynamics, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Aug 24, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Device Story

AngioDynamics Soft-Vu and Mariner catheters are diagnostic intravascular catheters. Devices facilitate angiographic diagnosis by providing a pathway for contrast media delivery within the vascular system. Used by physicians in clinical settings (e.g., interventional radiology, cardiology). Catheters feature hydrophilic coatings to enhance trackability and reduce friction during navigation through vasculature. Output is the successful delivery of contrast agent to target vessels for imaging. Benefits include improved maneuverability and diagnostic visualization.

Clinical Evidence

Bench testing only.

Technological Characteristics

Diagnostic intravascular catheter; hydrophilic coating; dimensions and form factor consistent with standard angiographic catheters; class II device (21 CFR 870.1200).

Indications for Use

Indicated for patients requiring angiographic diagnosis. Prescription use only.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2006

AngioDynamics, Inc. c/o Ms. Teri Juckett Regulatory Affairs Manager 603 Queensbury Ave Oueensbury, NY 12804

Re: K061733

AngioDynamics Soft-Vu and AngioDynamics Mariner Hydrophilic Coated Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO Dated: July 26, 2006 Received: August 2, 2006

Dear Ms. Juckett:

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 Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Teri Juckett

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 electronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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/industry/support/index.html.

Sincerely yours,

vina R. buchner

A 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

K 061733

510(k) Application: Special 510(k) Device Modification

Device Name: ANGIODYNAMICS Soft-Vu and ANGIODYNAMICS Mariner Hydrophilic Coated Catheters

## Indications for Use:

AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-the-Counter Use

Please do not write below this line - continue on another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diana R. Vachner

(Division Sign-Off Division of Cardiovascular Devices

510(k) Number K061733

Soft-Vu Product Line Extension 510(k) Design History File 350