CREATION NM DIAGNOSTIC CATHETERS

K032888 · Neich Medical (Shenzhen) Company Limited · DQO · Feb 24, 2004 · Cardiovascular

Device Facts

• Record ID: K032888
• Device Name: CREATION NM DIAGNOSTIC CATHETERS
• Applicant: Neich Medical (Shenzhen) Company Limited
• Product Code: DQO · Cardiovascular
• Decision Date: Feb 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

Neich Medical Creation NM™ Diagnostic Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Device Story

Creation NM™ Diagnostic Catheter is a vascular catheter used to deliver radiopaque contrast medium to specific sites within the vascular system. Operated by physicians in clinical settings, the device facilitates diagnostic imaging by enabling targeted contrast delivery. The catheter functions as a conduit for contrast media, allowing for visualization of vascular structures during interventional or diagnostic procedures. It is a passive device without electronic components or software.

Clinical Evidence

Bench testing only.

Technological Characteristics

Diagnostic catheter for vascular use. Intended for delivery of radiopaque contrast media. Class II device (21 CFR 870.1200).

Indications for Use

Indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system for diagnostic imaging purposes.

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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## FEB 2 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neich Medical (Shenzhen) Co., Ltd. c/o Mr. Raymond Lin No 1. Jinkui Road, Futian Free Trade Zone Shenzhen 518038, China

> K032888 Crcation NMTM Diagnostic Catheters Regulation Number: 870.1200 Regulation Name: Catheter, Intravascular, Diagnostic Regulatory Class: Class II Product Code: DQO Dated: December 16, 2003 Received: January 13, 2004

Dear Mr. Lin:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren o rely fee device 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 cholosure) to regars the Medical Device Amendments, or to commence print to May 20, 1978, the encordance with the provisions of the Federal Food, DNA and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costlictic Act (71ct) that to not required to the general controls provisions of the Act. The r ou may, therefore, mainte of the Act include requirements for annual registration, listing of general controls promotive, 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 to such additional controls. Existing major regulations affecting your device can may be subject to saterial Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Coursements concerning your device in the Federal Register.

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Page 2 – Mr. Raymond Lin

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a substinates with other requirements of the Act
that FDA has made a determination that your device also anancies. You must that FDA has made a determilation that your areas by other Federal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (2)
comply with all the Act's requirements, including, but not be registration asset comply with all the Act S requirements, increases and manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good if applicable, the electronic CFR Part 807); labeling (21 CFX 1 all 801); good manata 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and 11, CFP 100 forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Scellons 55 r c vice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a l This letter will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, p premarket notification. The PDA initing of substantial equive and thus, permits your device to proceed to the market.

lf 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 our car idocing.
contact the Office of Compliance at [phone]. Additionally, for questions of Compliance at 3 contact the Office of Compliance at (301) 59 + 10 + 1 cc the Office of Compliance at (301) 594promotion and advertising of your device, please contact the office of Complia promotion and advertising of your de reatified. "Misbranding by reference to premarket 46.39. Also, please note the regulation only obtain. Other general information on your notification" (21CFR Fall 807.97) you may obtained from the Division of Small Manufacturers, responsibilities under the Acc may of Counties [phone] or [phone]
International and Consumer Assistance at its toll-free number [phone]
International and International and Consumer : //www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dina R. Richter

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

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## Instructions For Use

510(K) Number: K032888

Device Name: Creation NM™ Diagnostic Catheter

## Indications For Use:

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Neich Modical Creation NM™ Diagnostic Catheters are designed to deliver radiopaque contrast thediturn to selected sites in the vascular system,

> Prescription Use (Part 21 CFR \$01 Subpart D)

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma R. V. Aunes

sion Sir -Off) (Div Division of Cardiovascul Devices

510(k) Number_Ko32888