MODIFICATION TO FETCH ASPIRATION CATHETER

K081989 · Possis Medical, Inc. · QEZ · Sep 26, 2008 · Cardiovascular

Device Facts

• Record ID: K081989
• Device Name: MODIFICATION TO FETCH ASPIRATION CATHETER
• Applicant: Possis Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fetch® Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.

Device Story

Fetch Aspiration Catheter is a rapid-exchange, low-profile, dual-lumen catheter; tracks over 0.014" guidewire. Used for aspiration of fresh, soft emboli and thrombi from arterial/coronary vessels. Operated by physicians in clinical settings. System includes catheter, extension line, 30 cc syringe, one-way stopcock, and 40-micron collection basket. Physician advances catheter through 6F guiding catheter to target site; applies manual aspiration via syringe to remove thrombus. Collected material filtered through basket for potential lab analysis. Device facilitates mechanical removal of obstructions to restore blood flow.

Clinical Evidence

Bench testing only; includes mechanical testing, biocompatibility testing, and sterility assessment.

Technological Characteristics

Rapid-exchange, dual-lumen catheter; 0.052" (4F) outer diameter; 0.014" guidewire compatible; radiopaque marker at distal tip; includes 40-micron collection basket. Mechanical aspiration principle.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from arterial and coronary vessels.

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

• Fetch Aspiration Catheter (K062172)
• Fetch Aspiration Catheter (K070363)

Submission Summary (Full Text)

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May 20, 2021

Possis Medical, Inc. Mike Burnside 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003

Re: K081989

Trade/Device Name: Fetch Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Mike Burnside:

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 September 26, 2008. 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], Gregory. Oconnell(@FDA.HHS.gov.

Sincerely.

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.05.20

Gregory O'Connell Assistant Director Plaque Modification Devices Team 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

SEP 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Possis Medical Inc. c/o Mr. Mike Burnside Regulatory Affairs Manager 9055 Evergreen Boulevard N.W. Minneapolis, MN 55433-8003

Re: K081989

> Trade/Device Name: Fetch® Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Catheter, Embolectomy Regulatory Class: Class II Product Code: DXE Dated: August 29, 2008 Received: September 2, 2008

Dear Mr. Burnside:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 agencics. 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

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Page 2 - Mr. Mike Burnside

systems (OS) 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 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), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

R. Vochner

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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## Indication for Use

510(k) Number (if known): K Ø 8 | 989

Device Name: The Fetch® Aspiration Catheter

Indications for Use:

The Fetch Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna D. Holmes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_上08|989

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## SEP 2 6 2008

:

## Section 5 - 510k Summary Information

:

| Applicant: | Possis Medical, Inc.<br>9055 Evergreen Boulevard N.W.<br>Minneapolis, MN 55433-8003<br>Tel: [phone]<br>Fax: [phone] ERN: 2183460 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike Burnside<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax:<br>[phone]<br>Email:<br>[e-mail] |
| Date Prepared: | July 11, 2008 |
| Trade Name: | Fetch® Aspiration Catheter |
| Common Name of<br>Device/ Classification<br>and Code: | Catheter,Embolectomy<br>Product Code: DXE<br>Class II/21 CFR 870.5150 Cardiovascular |
| Predicate Device: | The Fetch Aspiration Catheter - K062172 and K070363<br>Possis Medical, Inc.<br>9055 Evergreen Boulevard N.W.<br>Minneapolis, MN 55433-8003 |
| Device Description: | The FETCH Aspiration Catheter is a rapid exchange, low-profile tip,<br>dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track to<br>the target site. It is used for aspiration of fresh, soft emboli and thrombi<br>Its outer diameter 0.052" (1.33 mm) or 4F allows advancement to the<br>target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque<br>marker is located about 2 mm from the distal tip. FETCH is provided<br>with an extension line, 30 cc syringe, one-way stopcock and a 40<br>micron collection basket. This basket can be used to filter aspirated<br>blood for laboratory analysis of collected thrombus. |
| Intended Use: | The Fetch® Aspiration Catheter is indicated for the removal of fresh,<br>soft emboli and thrombi from vessels in the arterial system and<br>coronary vasculature. |
| Summary of<br>Technological<br>Characteristics: | Representative samples of the device underwent testing including but<br>not limited to mechanical testing, biocompatibility testing, and<br>sterility assessment. |
| Conclusion: | Possis Medical, Inc. considers the Fetch Aspiration Catheter to be<br>substantially equivalent to the predicate device listed above.<br>This<br>conclusion is based upon the devices' similarities in functional design,<br>materials, indications for use, and principles of operation. |