VYGON MICRO-ACCESS SAFETY INTRODUCER KIT

K051248 · Vygon Corp. · DYB · Oct 27, 2005 · Cardiovascular

Device Facts

• Record ID: K051248
• Device Name: VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
• Applicant: Vygon Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

This introducer kit is intended for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.

Device Story

Vygon Micro-Access Safety Introducer Kit facilitates percutaneous vascular access. Device used by clinicians to introduce diagnostic or therapeutic catheters or pacing leads into vasculature. Kit components enable safe access; operation involves standard percutaneous insertion techniques. Device serves as conduit for subsequent medical procedures; benefits include reliable vascular access for clinical interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Catheter introducer kit; percutaneous access design. Materials and specific technical standards not detailed in provided text. Device is a mechanical accessory for vascular access.

Indications for Use

Indicated for percutaneous introduction of diagnostic or therapeutic devices (e.g., catheters, pacing leads) into the vasculature. No specific patient population, age, or gender restrictions provided.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 2005

Vygon Corporation c/o Mr. Courtney Smith Regulatory Affairs/Quality Assurance Manager 2495 General Armistead Avenue Norristown, PA 19403-3685

Re: K051248 Vygon Micro-Access Safety Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: August 29, 2005 Received: September 1. 2005

## Dear Mr. Smith:

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 -- Mr. Courtney Smith

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA s issualic complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that I DA nas made a decemmanon that your as read by other Federal agencies. You must a or any Federal statules and regulations administered or registration and listing (21
comply with all the Act's requirements, including, but not manages as set comply with an the Act s requirements, me, good manufacturing practice requirements as setter CFR Part 807); labening (21 CFR Part 800); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and STD, 1000-1 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (occions of review as described in your Section 510(k)
This letter will allow you to begin marketing your device of section of vice to le I his letter will anow you to begin hankeling your antial equivalence of your device to a legally premarket notification. The PDA miding of substantial experience of 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 If you desire specific advice for your de rice of the career note the regulation entitled, the regulation entitled, comaci the Office of Companies at (210) = 1.7 = 1.7 = 1.807.97). You may obtain " Misbranding by reference to premance notifications of the Act from the Division of Small other general information on your responsible in the toll-free number (800) 63-204) or html Manufacturers, international and Consanter Phistown: fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blummenhofer

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):

Vygon Micro-Access Safety Introducer Kit Device Name:

Indications For Use:

This introducer kit is intended for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

R.B. Remick

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on Sign-Off Division of Cardiovascular Devices 510(k) Number