CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS

K992347 · Cordis Corp. · DQO · Oct 8, 1999 · Cardiovascular

Device Facts

• Record ID: K992347
• Device Name: CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
• Applicant: Cordis Corp.
• Product Code: DQO · Cardiovascular
• Decision Date: Oct 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Super Torque MB Angiographic Catheter with radiopaque marker bands is intended to provide angiographic visualization and linear measurements of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

Device Story

The Cordis Super Torque MB Angiographic Catheter is a 5.0 F single-lumen, braided catheter featuring 2 to 20 radiopaque gold-alloy marker bands mounted on a non-braided tip. Used by physicians in clinical settings to deliver radiopaque contrast media to the vascular system; the marker bands allow for linear measurements of the vasculature under imaging. The device facilitates angiographic visualization, aiding clinicians in assessing vascular anatomy and dimensions to inform clinical decision-making during interventional procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

5.0 F single-lumen braided catheter; 65 cm to 125 cm lengths; 2 to 20 gold-alloy radiopaque marker bands on non-braided tip. Biocompatible materials.

Indications for Use

Indicated for angiographic visualization and linear measurement of the vasculature in patients requiring delivery of radiopaque contrast media 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 5.2 F Super Torque Plus Angiographic Catheter
• Cook Aurous™ Graduated Sizing Catheter
• Guidant EVT AngioScale Angiographic Catheter

Submission Summary (Full Text)

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Super Torque MB Angiographic Catheter with Radiopaque Marker Bands Cordis Corporation, a Johnson & Johnson Company

510(k) Premarket Notification

1992347

## 510(k)

## Summary of Safety and Effectiveness

| General<br>Provisions | The name of the device is: | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| | Proprietary Name | Common or Usual Name |
| | Cordis Super Torque MB Angiographic Catheter<br>with Radiopaque Marker Bands | Angiographic Catheter<br>with Marker Bands |
| Name of<br>Predicate<br>Devices | The device is substantially equivalent to:<br>• Cordis 5.2 F Super Torque Plus Angiographic Catheter<br>• Cook Aurous™ Graduated Sizing Catheter<br>• Guidant EVT AngioScale Angiographic Catheter | |
| Classification | Class II. | |
| Performance<br>Standards | Performance standards have not been established by the FDA under<br>section 514 of the Food, Drug and Cosmetic Act. | |
| Indications for<br>Use | The Super Torque MB Angiographic Catheter with radiopaque marker<br>bands is intended to provide angiographic visualization and linear<br>measurements of the vasculature when combined with the delivery of<br>radiopaque contrast media to selected sites in the vascular system. | |
| Device<br>Description | The Cordis Super Torque MB Angiographic Catheter with radiopaque<br>marker bands consists of a 5.0 F single lumen, braided catheter having a<br>minimum of two and maximum of twenty radiopaque, gold-alloy,<br>marker bands circumferentially mounted on the a non-braided<br>catheter tip.<br><br>The Super Torque MB Angiographic Cathete with radiopaque marker<br>bands will be offered in catheter lengths ranging from 65 cm to 125<br>cm. | |
| Biocompatibility | All materials used in the Cordis Super Torque MB Angiographic Catheter with radiopaque marker bands are biocompatible. | |
| Summary of Substantial Equivalence | The Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands is substantially equivalent to the predicate devices. The equivalence was confirmed through non-clinical tests and analyses. | |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Public Health Service

OCT 8 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Wilk Senior Regulatory Affairs Associate Cordis Corporation P.O. Box 4917 Warren, NJ 07059

Re: K992347 Trade Name: Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands Requlatory Class: II Product Code: DQO Dated: July 13, 1999 Received: July 14, 1999

Dear Ms. Wilk:

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 aqainst 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 requlation (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 In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to

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Page 2 - Ms. Karen Wilk

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 requlations.

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 requlation (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 (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. 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.qov/cdrh/dsma/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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510(k) Premarket Notification

K992347

510(k) Number: Device Name:

Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands

Indications for Use: The Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

M. Ruc

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, And Radiological Devices

510(k) Number K992347