NEICH NM ADVANCE CATHETER SHEATH INTRODUCER

K020964 · Neich Medical(Shenzhen)Company, Ltd. · DYB · Oct 11, 2002 · Cardiovascular

Device Facts

• Record ID: K020964
• Device Name: NEICH NM ADVANCE CATHETER SHEATH INTRODUCER
• Applicant: Neich Medical(Shenzhen)Company, Ltd.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Catheter Sheath Introducer is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Device Story

The Neich Advance NM™ Catheter Sheath Introducer System is a medical device used to facilitate the percutaneous insertion of intravascular devices into the arterial or venous systems. It functions as a conduit, allowing clinicians to introduce catheters, guidewires, or other diagnostic/therapeutic tools into the vasculature. The system is intended for use by trained healthcare professionals in clinical settings. By providing a stable access point, the device enables minimally invasive procedures, reducing trauma to the vessel wall and simplifying the exchange of intravascular instruments during cardiovascular interventions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use.

Technological Characteristics

Catheter sheath introducer system; percutaneous access design; Class II device (21 CFR 870.1340); product code DYB.

Indications for Use

Indicated for patients undergoing arterial and venous procedures requiring percutaneous introduction of intravascular devices.

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

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### Public Health Service

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Neich Medical (Shenzhen) Co., Ltd. Mr. Huang Jin Manager, Quality Assurance & Regulatory Affairs No.1 Jinkui Road. Futian Free Trade Zone Shenzhen, 518038, China

- K020964 Re:
Trade/Device Name: Neich Advance NM™ Catheter Sheath Introducer System Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: July 25, 2002 Received: July 29, 2002

Dear Mr. Jin:

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 - Mr. Huang Jin

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Klatell

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section 3 – Indications For Use

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The Catheter Sheath Introducer is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

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**Prescription Use**
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K020964

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