ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001

K090253 · Possis Medical, Inc. · QEZ · Apr 8, 2009 · Cardiovascular

Device Facts

• Record ID: K090253
• Device Name: ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
• Applicant: Possis Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Apr 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from . Upper and Lower extremity peripheral arteries > 3 mm in diameter . Upper extremity peripheral veins > 3 mm in diameter . Ileofemoral and lower extremity veins ≥ 3 mm in diameter . . AV access conduits > 3 mm in diameter and . For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from . Upper and Lower extremity peripheral arteries ≥ 3 mm in diameter . . Upper extremity peripheral veins > 3 mm in diameter . . lleofemoral and lower extremity veins > 3 mm in diameter . . A V access conduits > 3 mm in diameter and . For use with the AngioJet Ultra Power Pulse Kit for the control and selective . infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system

Device Story

Sterile, single-use, disposable thrombectomy sets (DVX and Xpeedior catheters) used with AngioJet Ultra Console; designed for mechanical thrombus fragmentation and removal. Catheters feature 3-port manifold for contrast/fluid injection. Operated by physicians in clinical settings; system uses rheolytic principle to break apart thrombi. Output is removal of vascular obstructions and targeted delivery of thrombolytic agents. Benefits include restoration of blood flow in peripheral vasculature and AV access conduits.

Clinical Evidence

Bench testing and biocompatibility testing only; no clinical data provided.

Technological Characteristics

Sterile, single-use, disposable embolectomy catheters with 3-port manifold. Rheolytic mechanical thrombectomy principle. Designed for use with AngioJet Ultra Console. Materials and specifications consistent with predicate devices.

Indications for Use

Indicated for patients requiring thrombus removal from upper/lower extremity peripheral arteries, upper extremity veins, ileofemoral/lower extremity veins, and AV access conduits (all > 3 mm diameter). Also indicated for selective infusion of physician-specified fluids/thrombolytics into the peripheral vascular system using the Power Pulse Kit.

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 AVX Thrombectomy Set with injection (K082382)
• AngioJet Ultra DVX Thrombectomy Set (K072269)
• AngioJet Ultra Xpeedior Thrombectomy Set (K071342)
• AngioJet Xpeedior Rheolytic Thrombectomy Catheter (K071336)
• AngioJet Xpeedior Rheolytic Thrombectomy Catheter (K071514)
• AngioJet Xpeedior Catheter (K993564)
• AngioJet LF140 Catheter (K960970)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

May 20, 2021

MEDRAD Interventional/Possis Doug Atkins Sr Regulator Affairs Specialist 9055 Evergreen Blvd., NW Minneapolis, Minnesota 55433-8003

Re: K090253

Trade/Device Name: AngioJet Ultra DVX And Xpeedior Thrombectomy Sets Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Doug Atkins:

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 8, 2009. 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 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 -O'connell -S Date: 2021.05.20 09:37:08 -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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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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MEDRAD Interventional/Possis c/o Mr. Doug Atkins Senior Regulatory Affairs Associate 9055 Evergreen Blvd. NW Minneapolis, MN 55433-8003

APR - 8 2009

Re: K090253

> Trade/Device Name: AngioJet Ultra DVX Thrombectomy Set and AngioJet Xpeedior Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulatory Class: Class II Product Code: DXE, KRA Dated: January 30, 2009 Received: February 2, 2009

Dear Mr. Atkins;

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 of 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 - Mr. Doug Atkins

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,

M. S. Allehenne

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

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### Indications for Use

510(k) Number (if known): K0610253

Device Name: AngioJet® Ultra DVX® Thrombectomy Set

#### Indications for Use:

The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from

- . Upper and Lower extremity peripheral arteries > 3 mm in diameter
- . Upper extremity peripheral veins > 3 mm in diameter
- Ileofemoral and lower extremity veins ≥ 3 mm in diameter .
- . AV access conduits > 3 mm in diameter and
- . For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| M.A. Hillier |
|------------------------------------|
| (Division Sign-Off) |
| Division of Cardiovascular Devices |

| 510(k) Number | k090253 |
|---------------|---------|
|---------------|---------|

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### Indications for Use

510(k) Number (if known): K0910353

Device Name: AngioJet® Ultra Xpeedior® Thrombectomy Set

### Indications for Use:

The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from

- Upper and Lower extremity peripheral arteries ≥ 3 mm in diameter .
- Upper extremity peripheral veins > 3 mm in diameter .
- lleofemoral and lower extremity veins > 3 mm in diameter .
- . A V access conduits > 3 mm in diameter and
- For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of ● physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) 91 Hillelie M

(Division Sign-Off) Division of Cardiovascular Devi

510(k) number K090253

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K090253 page 1 of 2

# APR - 8 2009

| 5. 510(k) Summary | APR - 8 2009 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | MEDRAD Interventional / Possis<br>(MIP)9055 Evergreen Boulevard, N.W.<br>Coon Rapids, MN 55433 |
| Contact Person: | Doug Atkins<br>Sr. Regulatory Affairs Associate<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Common Name: | Embolectomy Catheter |
| Device Trade Name: | AngioJet® Ultra DVX® Thrombectomy Set and<br>AngioJet® Ultra Xpeedior® Thrombectomy Set |
| Device Classification Name: | Embolectomy Catheter |
| Predicate Devices: | AngioJet AVX Thrombectomy Set with injection (K082382)<br>AngioJet Ultra DVX Thrombectomy Set (K072269)<br>AngioJet Ultra Xpeedior Thrombectomy Set (K071342)<br>AngioJet Xpeedior Rheolytic Thrombectomy Catheter<br>(K071336)<br>AngioJet Xpeedior Rheolytic Thrombectomy Catheter<br>(K071514)<br>AngioJet Xpeedior Catheter (K993564)<br>AngioJet LF140 Catheter (K960970) |
| Device Description | |

## Device Description

AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include the AngioJet DVX and Xpeedior Thrombectomy catheters and a pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the bloodstream where the catheter is positioned.

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## Indications for Use

The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from the:

- Upper and Lower extremity peripheral arteries > 3 mm in diameter .
- . Upper extremity peripheral veins > 3 mm in diameter
- Ileofemoral and lower extremity veins > 3 mm in diameter .
- A V access conduits > 3 mm in diameter and .
- For use with the AngioJet Ultra Power Pulse Kit for the control and selective . infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system

## Comparison to Predicate Devices

MEDRAD Interventional / Possis (MIP) considers the AngioJet Ultra DVX and Xpeedior Thrombectomy Sets to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation.

### Supporting Information

Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions for using the AngioJet Ultra DVX and Xpeedior Thrombectomy Set to inject contrast media and other fluids into the bloodstream where the catheter is positioned.