CORDIS TEMPO ANGIOGRAPHY CATHETER

K991673 · Cordis Corp. · DQO · May 26, 1999 · Cardiovascular

Device Facts

• Record ID: K991673
• Device Name: CORDIS TEMPO ANGIOGRAPHY CATHETER
• Applicant: Cordis Corp.
• Product Code: DQO · Cardiovascular
• Decision Date: May 26, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

Cordis Tempo™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.

Device Story

Single lumen angiography catheter; used for delivery of radiopaque contrast medium to selected vascular sites. Constructed of Polyamide and Polyurethane; includes proximal strain relief and hub. Compatible with 0.035" and 0.038" guidewires. Available in various diameters and tip configurations. Operated by physicians in clinical settings to facilitate diagnostic imaging. Device enables visualization of vasculature via contrast delivery, aiding clinical diagnosis of vascular conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single lumen catheter; materials: Polyamide (body, intermediate, distal tip) and Polyurethane (brite tip). Includes proximal strain relief and hub. Compatible with 0.035" and 0.038" guidewires. Lengths: 40-125 cm. Biocompatible materials.

Indications for Use

Indicated for the delivery of radiopaque contrast medium to selected sites in the vasculature for patients requiring diagnostic angiography.

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 Tempo™ Angiography Catheters (K973401)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

| General<br>Provisions | Trade Name: Cordis Tempo™ Angiography Catheters<br>Common/Classification Name: Diagnostic Intravascular Catheter |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices | Cordis Tempo™ Angiography Catheters (K973401) |
| Classification | Class II. |
| Performance<br>Standards | Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act. |
| Intended Use<br>and Device<br>Description | Cordis Tempo Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.<br>The device description of Cordis Tempo Angiography Catheters is as follows:<br>The Tempo catheters are single lumen catheters consisting of Polyamide (body, intermediate and distal tip) and Polyurethane (brite tip) materials with a proximal strainrelief and hub. The catheters are available in various diameters and tip configurations. They are compatible with Guidewires with diameters of 0.035" and 0.038". |
| Biocompatibility | All materials used in the Tempo Angiographic Catheters are biocompatible. |
| Summary of<br>Substantial<br>Equivalence | The Cordis Tempo™ Angiography Catheters (40 to 125 cm length) are substantially equivalent to the previously cleared Cordis Tempo Catheters (65 to 125 cm length). |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 1999

Ariel MacTavish, RAC Sr. Requlatory Affairs Associate Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014

K991673 Re :

> 4F Tempo™ Angiography Catheters Trade Name: Requlatory Class: II Product Code: DQO Dated: May 14, 1999 Received: May 17, 1999

Dear Ms. MacTavish:

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 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). 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Reqister. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices

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Page 2 - Ms. Ariel MacTavish

under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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), 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 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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#### Attachment 2

#### Indications for Use Statement

| 510(k) Number (if known) | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Tempo ^TM Angiography Catheter |
| Indications for Use | Cordis Tempo ^TM Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ohiton Smith Ar TC

Divisi and N 510(k)

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

OR

Over-The-Counter Use_