ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT

K040728 · AngioDynamics, Inc. · DYB · Jun 18, 2004 · Cardiovascular

Device Facts

• Record ID: K040728
• Device Name: ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT
• Applicant: AngioDynamics, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The AngioDynamics Inc. Percutaneous Introducers are intended for the introduction of balloon catheters, closed end catheters or angiographic catheters into the vasculature. AngioDynamics, Inc. Percutaneous Introducers are designed for use during procedures and are not intended for critical care use.

Device Story

Percutaneous introducer used to facilitate access to the vasculature for diagnostic or interventional catheter procedures. Device acts as a conduit for inserting balloon, closed-end, or angiographic catheters. Used in clinical settings by healthcare professionals; not for critical care. Provides mechanical access to the vascular system; does not perform diagnostic or therapeutic functions itself. Benefits patient by enabling minimally invasive catheter-based interventions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Percutaneous catheter introducer. Mechanical device for vascular access. No electronic components, software, or energy sources. Materials and design consistent with standard vascular introducer specifications.

Indications for Use

Indicated for the introduction of balloon, closed end, or angiographic catheters into the vasculature. Not intended for critical care use.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUN 1 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Teri Juckett Regulatory Affairs Specialist AngioDynamics, Inc. 603 Queensbury Avenue Oueensbury, NY 12804

K040728 Re:

Trade/Device Name: Percutaneous Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: March 18, 2004 Received: March 22, 2004

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.

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

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Page 2 - Ms. Teri Juckett

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21 CFR 1000-1050); var 11 - 150, st the Active Active Active 1000-1050, forth in the quality systems (QS) regulation (2 ~21 (2 %) =2 % =3 % =1 %) =1 % =1 % =1 % =1 % =1 % =1 % =1 % =1 % = product radiation control provisions (Sections 35 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a leval This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA imalig of substantial equive 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
r the If you desire specific advice for your device of carded on all of the successforms on the contact the Office of Compliance at (301) 594-40 contact the Office of Compliance at (301) 594promotion and advertising of your device, please contact the office of Complia promotion and advertising of your devices promoting by reference to premarket
4639. Also, please note the regulation entitled, "Misbrangroomeral information on vour 4639. Also, please note the regulation entires, other general information on your notification" (21CFR Part 807.97) you hay be obtained from the Division of Small Manufacturers,
responsibilities under the Act may be obtained from the Comments of 2001 or (3 responsibilities under the Act may be out instruction in Britiston of Soll) 638-2041 or [phone]
International and Consumer Assistance at its toll-free min brokes broke imernational and Consumer Abolstant Processor of States of Smamain.html

Sincerely yours,

Dina R. Vochmer

QA 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): K040728

AngioDynamics, Inc. Percutaneous Introducer Device Name:

Indications For Use:

The AngioDynamics Inc. Percutaneous Introducers are intended for the introduction of The AngloDynamics inc. Ferodianous introductions into the vasculature.
balloon catheters, closed end catheters or angiographic catheters into the vasculature.

AngioDynamics, Inc. Percutaneous Introducers are designed for use during AngloDynamios, inc. I ordains and are not intended for critical care use.

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)

Duma R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_KU40728