ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER

K050794 · Possis Medical, Inc. · QEZ · Apr 28, 2005 · Cardiovascular

Device Facts

• Record ID: K050794
• Device Name: ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
• Applicant: Possis Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Apr 28, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioJet DVX Rheolytic Thrombectomy Catheter is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥ 3mm in diameter.

Device Story

The AngioJet DVX is a 90 cm, 6 French, single-use catheter for thrombus removal in peripheral arteries. It operates via the AngioJet System, utilizing high-velocity saline jets directed backward at the distal tip to create a localized low-pressure zone (Bernoulli effect). This mechanism generates suction to break up and aspirate thrombus through an exhaust lumen. The device tracks over a 0.035" guidewire through an 8 French high-flow guide catheter. Used by physicians in clinical settings, the device provides mechanical thrombectomy to restore blood flow. The healthcare provider monitors the procedure via standard imaging, using the device to clear arterial obstructions, potentially improving patient outcomes by reducing thrombus burden.

Clinical Evidence

No clinical data provided; substantial equivalence is based on functional design, principles of operation, materials, and performance characteristics compared to the predicate device.

Technological Characteristics

90 cm, 6 French, single-use catheter; utilizes high-velocity saline jets for rheolytic thrombectomy; tracks over 0.035" guidewire; compatible with 8 French high-flow guide catheters (0.086" minimum ID); sterile; mechanical principle of operation (Bernoulli effect).

Indications for Use

Indicated for patients requiring thrombus removal from infra-inguinal peripheral arteries ≥ 3mm in diameter.

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

• AngioJet XPEEDIOR 120 Catheter (K040013)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 8, 2021

Possis Medical, Inc. Mark Stenoien Manager, Clinical & RA 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003

Re: K050794

Trade/Device Name: Angiojet DVX Rheolytic Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Mark Stenoien:

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 April 28, 2005. 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,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Pate: 2021.10.08
10:36:15 -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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Image /page/1/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

APR 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Possis Medical, Inc. c/o Mr. Mark Stenoien Manager, Clinical & Regulatory Affairs 9055 Evergreen Blvd. N.W. Minneapolis, MN 55433

Re: K050794

AngioJet® DVX™ Rheolytic™ Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (Two) Product Code: DXE Dated: March 28, 2005 Received: March 29, 2005

Dear Mr. Stenoien:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars) to regars and the Medical Device American Device of Days commerce prior to May 20, 1978, the accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merciole, market the act include requirements for annual registration, listing of general controls provisions or vice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a00 virols. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Mark Stenoien

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements not the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to I veally marketed predicate device results in a classification for your device and thus, permitts your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Dma R. Vochner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Page

510(k) Number (if known):

AngioJet® DVX™ Rheolytic™ Thrombectomy Catheter Device Name:

Indications for Use:

The AngioJet DVX Rheolytic Thrombectorny Catheter is intended for use with the AngioJet System in breaking apart and removing thromby Cameror 15 included to "die Will interies 2 3 mm in diameter.

ﯿﮯ

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Or

Over-the-Counter Use

Dma R. VcLunes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K050794

2 23 of 69

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KOSO794 10f1

## APR 2 8 2005

510(k) Summary

| Submitter: | Possis Medical, Inc.<br>9055 Evergreen Blvd. N.W.<br>Minneapolis, MN 55433<br>USA |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. James Gustafson<br>Vice President, Research, Development & Engineering<br>Possis Medical, Inc.<br>9055 Evergreen Blvd. N.W.<br>Minneapolis, MN 55433<br>USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 28, 2005 |
| Trade Name: | AngioJet® DVXT™ Rheolytic™ Thrombectomy Catheter |
| Classification<br>Name and No. | 21 CFR 870.5150<br>Embolectomy Catheter -Class II |
| Product Code: | DXE |
| Predicate Device | AngioJet XPEEDIOR® 120 Catheter under K040013 on 5/18/2004. |
| Device Description: | The AngioJet DVX Catheter is a 90 cm, 6 French, sterile, single-use<br>catheter designed for removing thrombus from vascular conduits. High<br>velocity saline jets directed back into the Catheter create a localized<br>low-pressure zone at the distal tip (Bernoulli effect) that results in<br>suction, break-up, and removal of thrombus through the exhaust lumen.<br>The Catheter is designed to track over a 0.035" guide wire and through<br>an 8 French high flow guide catheter (0.086 inch minimum internal<br>diameter), which allows sufficient passage of the Catheter with adequate<br>clearance for injection of standard contrast media, if desired. |
| Intended Use: | The AngioJet DVX Rheolytic Thrombectomy Catheter is indicated for<br>use with the AngioJet System in breaking apart and removing thrombus<br>from infra-inguinal peripheral arteries ≥ 3mm in diameter. |
| Statement of<br>Technological<br>Comparison | The subject device have the following similarities:<br>• The same indication for use;<br>• The same operating principle;<br>• The same basic design;<br>• The same manufacturing environment;<br>• The same sterilization process; and<br>• The same packaging configurations.<br>In summary, the AngioJet DVX Catheter, as described in this<br>submission is, in the opinion of Possis Medical Inc., substantially<br>equivalent to the predicate device. |
| Conclusion: | The AngioJet DVX Catheter, as described in this submission, is<br>substantially equivalent to the predicate device, the XPEEDIOR 120<br>Catheter K040013. This conclusion is based upon the similarities of the<br>devices in terms of functional design, indication for use, principles of<br>operation, materials, and performance characteristics. |

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