← Product Code [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY) · K030715

# SAFFRON NM GUIDING CATHETER (K030715)

_Neich Medical (Shenzhen) Company Limited · DQY · Apr 24, 2003 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K030715

## Device Facts

- **Applicant:** Neich Medical (Shenzhen) Company Limited
- **Product Code:** [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY.md)
- **Decision Date:** Apr 24, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1250
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for Use

The Saffron NM™ Guiding Catheter is indicated for use for intravascular introduction of interventional/diagnostic devices into coronary or peripheral vascular systems.

## Device Story

Saffron NM™ Guiding Catheter is a percutaneous catheter used for intravascular introduction of interventional or diagnostic devices into coronary or peripheral vascular systems. Device is used in clinical settings by physicians during interventional procedures. It facilitates delivery of other devices to target vascular sites. Benefits include enabling minimally invasive access to coronary or peripheral vasculature for diagnostic or therapeutic purposes.

## Clinical Evidence

bench testing only

## Technological Characteristics

Percutaneous catheter; Class II; Product Code DQY; 21 CFR 870.1250.

## Regulatory Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

## Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle emblem. The eagle is depicted with three swooping lines forming its wings and body. 

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2003

Neich Medical (Shenzhen) Co., Ltd. Mr. Raymond Lin Manager, Regulatory Affairs No. 1 Jinkui Road Futian Free Trade Zone Shezhen 518038, China

Re: K030715

Trade/Device Name: Saffron NM™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: April 14, 2003 Received: April 16, 2003

Dear Mr. Lin:

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. Iisting 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

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Page 2 - Mr. Raymond Lin

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

V. Qalln T.M.
B. Zaleski, M.D.

ckerman, 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

: 上一篇:

The Saffron NM™ Guiding Catheter is indicated for use for intravascular introduction of interventional/diagnostic devices into coronary or peripheral vascular systems.

Prescription Use Only

Koffler

(Division Sian-Division of Cardiovascular Devices

510(k) Number K030745

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