4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER

K971646 · Cordis Corp. · DQO · Jul 14, 1997 · Cardiovascular

Device Facts

• Record ID: K971646
• Device Name: 4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER
• Applicant: Cordis Corp.
• Product Code: DQO · Cardiovascular
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Cordis 4 F and 5 F Nylex™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.

Device Story

Single lumen angiography catheters; radiopaque body and tip. Used by clinicians to deliver radiopaque contrast medium to specific vascular sites. Facilitates visualization of vasculature during diagnostic procedures. Device is a modification of existing Nylex™ catheter lines.

Clinical Evidence

Bench testing only; biocompatibility testing performed on materials.

Technological Characteristics

Single lumen catheter; radiopaque body and tip. 4 F and 5 F sizing. No software or electronic components.

Indications for Use

Indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system. Prescription use only.

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.

Predicate Devices

• Cordis Corporation 4 F Nylex™ Angiography Catheter (K962759)
• Cordis Corporation 5 F Nylex™ Angiography Catheter (K930479)
• Cordis Corporation Envoy™ and Vista Brite Tip™ Guiding Catheter (K962362)

Submission Summary (Full Text)

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# 00-00033

K971646

## PREMARKET NOTIFICATION 510(k) Cordis Corporation 4 F and 5 F Nylex™ Angiography Catheters Modification

#### JUL | 4 1997 SUMMARY OF SAFETY AND EFFECTIVENESS

- General Provisions 1.
Common or Usual Name: Diagnostic and Intravascular Catheter and Percutaneous Catheter

Proprietary Name: Cordis 4 F Nylex™ Angiography Catheter and Cordis 5 F Nylex™ Angiography Catheter

- Name of Predicate Devices 11.
Cordis Corporation 4 F Nylex™ Angiography Catheter (K962759) Cordis Corporation 5 F Nylex™ Angiography Catheter (K930479) Cordis Corporation Envoy™ and Vista Brite Tip™ Guiding Catheter (K962362)

- III. Classification
Class II

- IV. Performance Standards
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.

- V. Intended Use and Device Description
The Cordis 4 F and 5 F Nylex™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.

The catheters included in this submission are single lumen catheters with a radiopaque body and tip.

- VI. Biocompatibility
All appropriate biocompatibility tests have been performed on the materials used for the modified 4 F and 5 F Nylex™ Angiography Catheters.

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## PREMARKET NOTIFICATION 510(k) Cordis Corporation 4 F and 5 F Nylex™ Angiography Catheters Modification

#### Summary of Substantial Equivalence VII.

The Cordis F 4 and F 5 Nylex™ Angiography Catheters are similar in design, construction, indication for use and performance characteristics to other commercially available angiography catheters.

A statement of substantial equivalence to another product is required by 21CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " .. a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seg. (1977)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elena S. Jugo, M.D. Manager, Regulatory and Clinical Affairs Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700

JUL 1 4 1997

Re: K971646 4 Fr and 5 Fr Nylex™ Angiography Catheters Regulatory Class: II (two) Product Code: DQO Dated: May 2, 1997 Received: May 5, 1997

Dear Dr. Jugo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), přease 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## PREMARKET NOTIFICATION 510(k) Cordis Corporation 4 F and 5 F Nylex™ Angiography Catheters Modification

00-00055

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: 4 E and 5 E Nylex TM Angiography Catheters_________

Indications for Use:

Cordis Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

ThAK

(Division Sign-On
Division of Caronwascular Respiratory,
and Neurological Devices 71146

510(k) Number -

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use