MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER

K990805 · Cordis Corp. · QEZ · Mar 15, 1999 · Cardiovascular

Device Facts

• Record ID: K990805
• Device Name: MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER
• Applicant: Cordis Corp.
• Product Code: QEZ · Cardiovascular
• Decision Date: Mar 15, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.

Device Story

The Cordis 7F Hydrolyser Thrombectomy Catheter is a dual-lumen catheter (65-100 cm length) designed for percutaneous removal of soft, fresh thrombus from dialysis shunts. The device operates via a fluid-based mechanism: saline is injected through an injection lumen to create a localized effect, and the resulting fluid/thrombus mixture is transported out through an exhaust lumen into a collection bag. It is used by clinicians in a clinical setting. The device provides a mechanical means for thrombus removal, potentially restoring shunt patency and benefiting patients by avoiding more invasive surgical interventions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dual-lumen catheter (65-100 cm length); injection lumen for saline; exhaust lumen for fluid/thrombus transport; biocompatible materials; 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 (65 cm length)

Submission Summary (Full Text)

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October 8, 2021

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

Re: K990805

Trade/Device Name: Cordis 7F 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 March 15, 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(a)FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell 5 O'connell -S Date: 2021.10.08 10:43:35 -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

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Ariel MacTavish, RAC Senior Regulatory Affairs Associate Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014

Re: K990805 Trade Name: Modification to 7F Hydrolyser Thrombectomy Catheter Requlatory Class: II Product Code: DXE Dated: March 10, 1999 March 11, 1999 Received:

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 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 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to

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Page 2 - Ms. Ariel MacTavish

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 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. 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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### Attachment 2

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## Indications for Use Statement

| 510(k) Number (if known) | K990805 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Device Name | Cordis 7F Hydrolyser Thrombectomy Catheter |
| Indications for Use | The 7F 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)

Ch. To. Am. Awn

(Division Sign-O Division of Cardiovas and Neurological De 510(k) Number

Cordis 7F Hydrolyser Line Extension Special 510(k) March, 1999

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# Attachment 4

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# Summary of Safety and Effectiveness

| General<br>Provisions | The name of the device is: | |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | Proprietary Name | Common or Usual Name |
| | Cordis 7F Hydrolyser Thrombectomy Catheter<br>(65 – 100 cm length) | Embolectomy Catheter |
| Name of<br>Predicate<br>Devices | The device is substantially equivalent to:<br>• Cordis 7F Hydrolyser Thrombectomy Catheter (65 cm length) | |
| Classification | 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 7F Hydrolyser is indicated to percutaneously remove soft, newly formed<br>(≤ 5 days old) thrombus from dialysis shunts. | |
| Device<br>Description | The Cordis 7F Hydrolyser Thrombectomy Catheter system consists of a 7F<br>Catheter and an Accessory Kit. | |
| | The 7F Catheter is a 65 - 100 cm dual lumen catheter which consists of an<br>injection lumen that allows for saline to be injected and an exhaust lumen that<br>allows for the fluid to be transported into a collection bag. | |
| Biocompatibility | All materials used in the Cordis 7F Hydrolyser Thrombectomy Catheter are<br>biocompatible. | |
| Summary of<br>Substantial<br>Equivalence | The Cordis 7F Hydrolyser Thrombectomy Catheter is substantially equivalent<br>to the predicate device. The equivalence was confirmed through pre-clinical<br>testing. | |
| Cordis 7F Hydrolyser Line Extension<br>Special 510(k)<br>March, 1999 | | 16 |