MEDTRONIC ANGIOGRAPHIC CATHETER

K980973 · Medtronics Interventional Vascular · DQO · Dec 10, 1998 · Cardiovascular

Device Facts

• Record ID: K980973
• Device Name: MEDTRONIC ANGIOGRAPHIC CATHETER
• Applicant: Medtronics Interventional Vascular
• Product Code: DQO · Cardiovascular
• Decision Date: Dec 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Medtronic® Angiographic Catheter is designed to be used for delivering radiopaque media and making pressure measurements in selected coronary sites within the vascular system.

Device Story

The Medtronic Angiographic Catheter is a diagnostic intravascular device used by clinicians to deliver radiopaque contrast media and perform pressure measurements within coronary sites. The device features a braided proximal shaft, a non-braided distal segment, and various tip configurations. It is available in 4F, 5F, 6F, and 7F diameters. The catheter is inserted into the vascular system to facilitate diagnostic imaging and hemodynamic assessment. By enabling precise contrast delivery and pressure monitoring, the device assists physicians in evaluating coronary anatomy and function, supporting clinical decision-making during angiographic procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing was successfully performed on all materials. No clinical data provided.

Technological Characteristics

Diagnostic intravascular catheter; 4F, 5F, 6F, and 7F diameters; braided proximal shaft; non-braided distal segment; various tip configurations. Materials underwent biocompatibility testing.

Indications for Use

Indicated for use in patients requiring delivery of radiopaque contrast media and pressure measurements within coronary sites of 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

• Medtronic Cascade® Angiographic Catheter
• USCI® Angiographic Catheter

Submission Summary (Full Text)

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K980973

Medtronic® Angiographic Catheter

## DEC 1 0 1998 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)

- 1. The trade or proprietary name of the device is the Medtronic® Angiographic Catheter. Models offered in this product line include Medtronic® 4F Angiographic Catheter, Medtronic® 5F Angiographic Catheter, Medtronic® 6F Angiographic Catheter and Medtronic® 7F Angiographic Catheter. The classification name is Diagnostic Intravascular Catheter.
- 2. The Medtronic® Angiographic Catheter is designed to be used for delivering radiopaque media and making pressure measurements in selected coronary sites within the vascular system.
- 3. The Medtronic® Angiographic Catheters are 4F, 5F, 6F and 7F in diameter with a braided proximal shaft, non-braided distal segment and a variety of tip configurations.
- 4. All appropriate biocompatibility tests were successfully performed on the materials used for the Medtronic® Angiographic Catheters.
- 5. Test results verified that the Medtronic® Angiographic Catheter meets all of the applicable specifications and is deemed adequate for the intended use. The line of angiographic catheters is considered to be substantially equivalent to the following devices:
- . Medtronic Cascade® Angiographic Catheter
- . USCI® Angiographic Catheter

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a stylized bird or human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1998

Mr. Mark Chartier Quality Assurance and Regualtory Affairs Manager Medtronic Interventional Vascular, Inc. 37A Cherry Hill Drive Danvers, MA 01923

Re : K980973 Trade Name: Medtronic® Angiographic Catheter Regulatory Class: II Product Code: DQO Dated: September 11, 1998 Received: September 14, 1998

Dear Mr. Chartier:

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 Regulation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation

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Page 2 - Mr. Mark Chartier

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.

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. Callehan

Thomas J. Callahe 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: | To be assigned by FDA |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Medtronic® Angiographic Catheter |
| Indications for Use: | The Medtronic® Angiographic Catheter is designed to be<br>used for delivering radiopaque media and making pressure<br>measurements in selected coronary sites within the vascular<br>system. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ice Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Device x 510(k) Number _

Prescription Use
(21 CFR 801.109)

Over-The-Counter Use OR

(Per 21 CFR 801.109)

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