TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)

K973401 · Cordis Corp. · DQO · Nov 18, 1997 · Cardiovascular

Device Facts

• Record ID: K973401
• Device Name: TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
• Applicant: Cordis Corp.
• Product Code: DQO · Cardiovascular
• Decision Date: Nov 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Cordis Tempo™ 4 Angiography Catheters are designed for the delivery of radiopaque contrast medium to selected sites in the vascular system.

Device Story

The Cordis Tempo™ 4 Angiography Catheter is a single-lumen diagnostic device used by clinicians to deliver radiopaque contrast medium to specific vascular sites. The catheter is constructed from polyamide and polyurethane, featuring a proximal strain relief and hub. It is available in various lengths and tip configurations to accommodate guidewires of 0.035" or 0.038" diameters. The device is used in a clinical setting to facilitate angiography procedures, allowing the physician to visualize the vascular system through the delivery of contrast media.

Clinical Evidence

No clinical data. Biocompatibility testing was successfully performed per ISO 10993-1.

Technological Characteristics

Single-lumen catheter; materials: polyamide and polyurethane; proximal strain relief and hub; compatible with 0.035" or 0.038" guidewires; various lengths and tip configurations available; biocompatibility tested per ISO 10993-1.

Indications for Use

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

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 4F Infinity™ Angiography Catheter

Submission Summary (Full Text)

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Ka973401

## Summary Of Safety And Effectiveness

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14 - 18

Status

| General<br>Provisions | The name of the device is: NOV 18 1997 | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| | Proprietary Name | Common or Usual Name |
| | Cordis Tempo™ 4 Angiography Catheter | Diagnostic Intravascular<br>Catheter and Percutaneous<br>Catheter |
| Predicate<br>Device | The name of the predicate device is:<br>• Cordis 4F Infinity™ Angiography Catheter | |
| Classification | The FDA has classified angiography catheters as Class II. | |
| Performance<br>Standards | Performance standards have not been established by the FDA under Section<br>514 of the Food, Drug, and Cosmetic Act. | |
| Indications for<br>Use | The Cordis Tempo™ 4 Angiography Catheters are designed for the delivery<br>of radiopaque contrast medium to selected sites in the vascular system. | |
| Device<br>Description | The Cordis Tempo™ 4 Angiography catheter is a single lumen catheter<br>consisting of polyamide and polyurethane materials with a proximal strain<br>relief and hub. The catheters are available in various lengths and tip<br>configurations and accept guidewires with diameters of 0.035" or 0.038"<br>depending on the configuration. | |
| | Continued on next page | |

PREMARKET NOTIFICATION Cordis Corporation
Tempo™ 4 Angiography Catheter

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## Summary Of Safety And Effectiveness, Continued

| Biocompatibility | All appropriate Biocompatibility tests were successfully performed on the<br>materials used for the Cordis Tempo™ 4 Angiography Catheters per ISO<br>10993-1. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Substantial<br>Equivalence | The Cordis Tempo™ 4 Angiography Catheter is similar in design,<br>construction, indication for use and performance characteristics to other<br>commercially available angiography catheters. |

^&#x27; Any statement of substantial equivalence to another product is required by 21 CFR 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 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 suuites." 42 Fed. Reg. 42,520, et seg. (1977).

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DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1997

Ms. Jacqueline Zimovan Regulatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700

Re : K973401 Tempo™ Angiography Catheter Requlatory Class: II (two) Product Code: DQO Dated: September 8, 1997 Received: September 9 1997

Dear Ms. Zimiovan:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 requlatory 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), 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" (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. Callahon

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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## INDICATIONS FOR USE

| | 510(K) Number (if known): [To be assigned by the FDA] |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Tempo TM 4 Angiography Catheter |
| Indications for Use: | The Cordis TempoTM 4 Angiography Catheter is designed to<br>deliver radiopaque contrast medium to selected sites in the vascular<br>system. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Tara A. Ry
(Division Sign-Off)

Division of Cardiovascular Respiratory, and Neurological Devices 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use _

PREMARKET NOTIFICATION

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Cordis Corporation Tempo™ 4 Angiography Catheter