Cordis Endeavor Infusion Catheter

K970842 · Cordis Corp. · QEY · May 28, 1997 · Cardiovascular

Device Facts

• Record ID: K970842
• Device Name: Cordis Endeavor Infusion Catheter
• Applicant: Cordis Corp.
• Product Code: QEY · Cardiovascular
• Decision Date: May 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cordis Endeavor Infusion Catheter is intended to deliver solutions, such as heparinized saline, and thrombolytic agents, such as urokinase, to the coronary and peripheral vasculature.

Device Story

The Cordis Endeavor Infusion Catheter is an over-the-wire catheter designed for targeted delivery of therapeutic solutions to coronary and peripheral vasculature. It features a distal infusion region and a proximal hub, with a central radiopaque marker band to assist in positioning. The device is operated by a physician in a clinical setting. By enabling localized infusion of agents like heparinized saline or thrombolytics, the catheter facilitates site-specific treatment, potentially improving therapeutic efficacy while minimizing systemic exposure.

Clinical Evidence

Bench testing and in vivo testing were performed. All test results met or exceeded established specifications. No clinical trial data provided.

Technological Characteristics

Over-the-wire catheter design; distal infusion region; proximal hub; radiopaque marker band for visualization. Materials passed biocompatibility testing.

Indications for Use

Indicated for delivery of solutions, including heparinized saline and thrombolytic agents (e.g., urokinase), to the coronary and peripheral vasculature.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• SciMed Dispatch and Dispatch Gold Infusion Catheters
• LocalMed InfusaSleeve and InfusaSleeve II Infusion Catheters
• Interventional Innovations Segue Infusion Catheter

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

January 7, 2022

Cordis Corp.
Tamara Yount
Regulatory & Clinical Affairs, Mgr.
14201 N.w. 60th Ave.
Miami Lakes, Florida 33014

Re: K970842
Trade/Device Name: Cordis Endeavor Infusion Catheter
Regulation Number: 21 CFR 870.5150
Regulation Name: Embolectomy catheter
Regulatory Class: Class II
Product Code: QEY, KRA

Dear Tamara Yount:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 28, 1997. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone], [e-mail].

Sincerely,

Gregory W. O'connell -S
Digitally signed by Gregory W. O'connell -S
Date: 2022.01.07
13:56:39 -05'00"

Gregory O'Connell
Assistant Director
DHT2C: Division of Coronary and Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 28 1997

Ms. Tamara Yount
Cordis Corporation
P.O. Box 025700
Miami, Florida 33014

Re: K970842
Cordis Endeavor Infusion Catheter
Regulatory Class: II (two)
Product Code: 74 KRA
Dated: March 6, 1997
Received: March 7, 1997

Dear Ms. Yount:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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Page 2 - Ms. Tamara Yount

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. 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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# Statement of Intended Use
## Cordis Endeavor Infusion Catheter

The intended use statement of this product is:

The Cordis Endeavor Infusion Catheter is intended to deliver solutions, such as heparinized saline, and thrombolytic agents, such as urokinase, to the coronary and peripheral vasculature.

510(k) number K970842
(To be assigned by FDA)


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K970842
MAY 28 1997

# Section 513(j) of the Federal Food, Drug and Cosmetic Act
## Summary of Safety and Effectiveness

March 5, 1997

## I. General Provisions

- **Common or Usual name:** Infusion Catheter
- **Proprietary name:** Cordis Endeavor Infusion Catheter
- **Name and Address of Applicant:** Cordis Corporation
Miami Lakes Operation Center
14201 NW 60 Avenue
Miami Lakes, FL 33014

## II. Name of Predicate Devices

- SciMed Dispatch and Dispatch Gold Infusion Catheters
- LocalMed InfusaSleeve and InfusaSleeve II Infusion Catheters
- Interventional Innovations Segue Infusion Catheter

## III. Classification

Infusion catheters are class II devices according to 21 CFR 870.1210.

## 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 Endeavor Infusion Catheter is intended to deliver solutions to the coronary and peripheral vasculature. The device is an over-the-wire design with a distal infusion region and a proximal hub. The infusion region is indicated by a central radiopaque marker band.

## VI. Biocompatibility

All appropriate biocompatibility testing was performed, and successfully passed, on the materials used for the Endeavor Infusion Catheter.

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# VII. In vitro Testing

A series of *in vitro* and *in vivo* tests were performed to assure that the introduction of the Endeavor Infusion Catheters does not raise new issues of safety and effectiveness. All test results met or exceeded established specifications.

# VIII. Summary of Substantial Equivalence

The Endeavor Infusion Catheter is designed for the infusion of solutions to the coronary and peripheral vasculature. The Endeavor Infusion Catheters have similar intended uses, design characteristics and dimensions as the predicate devices.

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