6F HYDROLYSER THROMBECTOMY CATHETER

K990771 · Cordis Corp. · QEZ · Jun 25, 1999 · Cardiovascular

Device Facts

• Record ID: K990771
• Device Name: 6F HYDROLYSER THROMBECTOMY CATHETER
• Applicant: Cordis Corp.
• Product Code: QEZ · Cardiovascular
• Decision Date: Jun 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 6F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.

Device Story

The Cordis 6F Hydrolyser Thrombectomy Catheter is a 65 cm triple-lumen catheter designed for percutaneous removal of soft, fresh thrombi from dialysis shunts. The system includes the catheter and an accessory kit. Operation involves injecting saline through an injection lumen to create a localized hydrodynamic effect that breaks up and aspirates thrombus; the resulting fluid and debris are transported through an exhaust lumen into a collection bag. A third lumen accommodates a guidewire for navigation. The device is used by clinicians in a clinical setting to restore patency in dialysis access sites, potentially benefiting patients by avoiding more invasive surgical interventions.

Clinical Evidence

Equivalence was confirmed through pre-clinical and clinical testing. Specific study metrics and results are not detailed in the provided documentation.

Technological Characteristics

65 cm triple-lumen catheter; lumens include injection, exhaust, and guidewire. Materials are biocompatible. Operates via hydrodynamic saline injection and aspiration. Class II device.

Indications for Use

Indicated for percutaneous removal of soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.

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

• Cordis 7F Hydrolyser Thrombectomy Catheter

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 8, 2021

Cordis Corp. Ariel MacTavish Senior Regulatory Affairs Associate 14201 N.w.60th Ave. Miami Lakes, Florida 33014

Re: K990771

Trade/Device Name: Cordis 6F Hydrolyser Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Ariel MacTavish:

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 June 25, 1999. Specifically, FDA is updating this SE Letter 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], Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.10.08 10:42:17 -04'00'

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

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and features the department's name around the perimeter. In the center of the seal is an emblem of a stylized eagle with its wings spread, symbolizing protection and service. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1999

Ms. Ariel MacTavish Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014

K990771 Re: 6F Hydrolyser Thrombectomy Catheter Regulatory Class: II (two) Product Code: 74 DXE Dated: June 9, 1999 Received: June 10, 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 Regulations, 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 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 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.

{2}------------------------------------------------

## Page 2 - Ms. Ariel MacTavish

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 [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/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

{3}------------------------------------------------

## Attachment 3

## Indications for Use Statement

| 510(k) Number (if known) | K990771 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Device Name | Cordis 6F Hydrolyser Thrombectomy Catheter |
| Indications for Use | The 6F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Christopher

(Division Sign-Off) Division of Cardiovascular, Resp and Neurological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

..

OR

{4}------------------------------------------------

Attachment 1

00-00021
K990771

## Summary of Safety and Effectiveness

:

| General<br>Provisions | The name of the device is: | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Proprietary Name | Common or Usual Name |
| | Cordis 6F Hydrolyser Thrombectomy Catheter | Embolectomy Catheter |
| Name of<br>Predicate<br>Device | The device is substantially equivalent to:<br>• Cordis 7F Hydrolyser Thrombectomy 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 6F Hydrolyser is indicated to percutaneously remove soft, newly<br>formed (≤ 5 days old) thrombus from dialysis shunts. | |
| Device<br>Description | The Cordis 6F Hydrolyser Thrombectomy Catheter system consists of<br>a 6F Catheter and an Accessory Kit. | |
| | The 6F Catheter is a 65 cm triple lumen catheter which consists of an<br>injection lumen that allows for saline to be injected, an exhaust lumen<br>that allows for the fluid to be transported into a collection bag and a<br>guidewire lumen. | |
| Biocompatibility | All materials used in the Cordis 6F Hydrolyser Thrombectomy<br>Catheter are biocompatible. | |
| Summary of<br>Substantial<br>Equivalence | The Cordis 6F Hydrolyser Thrombectomy Catheter is substantially<br>equivalent to the predicate device. The equivalence was confirmed<br>through pre-clinical and clinical testing. | |