FETCH ASPIRATION CATHETER

K070363 · Possis Medical, Inc. · QEZ · May 11, 2007 · Cardiovascular

Device Facts

• Record ID: K070363
• Device Name: FETCH ASPIRATION CATHETER
• Applicant: Possis Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: May 11, 2007
• Decision: SESE
• Submission Type: Traditional
• 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 coronary and peripheral vasculature.

Device Story

Rapid exchange, low-profile, dual-lumen aspiration catheter; tracks over 0.014" guidewire; advanced through 6F guiding catheter to target site. Used for aspiration of fresh, soft emboli and thrombi from coronary and peripheral vessels. Includes extension line, 30 cc syringe, one-way stopcock, and 40-micron collection basket for filtering aspirated blood. Operated by physicians in clinical settings. Radiopaque marker at distal tip aids visualization. Benefits patient by removing obstructive thrombi/emboli to restore blood flow.

Clinical Evidence

Preclinical animal testing performed to support substantial equivalence. No human clinical trial data provided.

Technological Characteristics

Rapid exchange, dual-lumen catheter; 4F outer diameter; 0.014" guidewire compatible; radiopaque distal marker; includes 40-micron collection basket. Mechanical aspiration via syringe.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from coronary and peripheral vasculature.

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

• Pronto Extraction Catheter (K042937)
• Pronto V3 Extraction Catheter (K063371)
• FETCH Aspiration Catheter (K062172)

Submission Summary (Full Text)

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September 15, 2021

Possis Medical, Inc. Frank Freedman Sr. RA Associate 9055 Evergreen Blvd., NW Minneapolis, Minnesota 55433-8003

Re: K070363

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

Dear Frank Freedman:

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 Mav 11, 2007. 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 Date: 2021.09.15
O'connell -S 09:25:19 -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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY I 1 2007

Possis Medical, Inc. c/o Dr. Frank Freedman, Ph.D. Sr. Regulatory Affairs Associate 9055 Evergreen Boulevard NW Minneapolis, MN 55433

Re: K070363 Fetch Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II (two) Product Code: DXE Dated: April 12, 2007 Received: April 16, 2007

Dear Dr. Freedman:

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, Or v 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, EDA max publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Frank Freedman, Ph.D.

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 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 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/industry/support/index.html.

Sincerely yours.

Duna R. bohner.

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

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Enclosure

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## Indications for Use

510(k) Number (if known): Ko 70363

Device Name: 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 coronary and peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Donna P. Holmes

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K070363

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K070363

# MAY 1 1 2007

| Device Common Name: | Embolectomy Catheter | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Device Trade Name: | FETCH™ Aspiration Catheter | |
| Device Classification/Name: | Class II | 21 CFR |
| | 870.5150<br>Embolectomy Catheter | Product code: DXE |
| Manufacturer: | Possis Medical, Inc.<br>9055 Evergreen Boulevard, N.W.<br>Minneapolis, MN 55433<br>Phone: [phone] | Fax: [phone] |
| Contact Person: | Submitter<br>Frank B. Freedman<br>Possis Medical, Inc. | Secondary Contact<br>Mark D. Stenoien<br>Possis Medical, Inc. |
| Performance Standards: | None have been developed for this device, per Section 514 | |
| Predicate Devices: | Pronto Extraction Catheter (K042937), Pronto V3 Extraction<br>Catheter (K063371) and FETCH Aspiration Catheter (K062172) | |

## Device Description

5.

510(k) Summary

The FETCH Aspiration Catheter is a rapid exchange, low-profile tip, dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track to the target site. It is used for aspiration of fresh, soft emboli and thrombi. Its outer diameter 0.052" (1.33 mm) or 4F allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an extension line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This basket can be used to filter aspirated blood for laboratory analysis of collected thrombus.

#### Indications for Use

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

## Comparison to Predicate Devices

The FETCH Aspiration Catheter is substantially equivalent to the Pronto Extraction Catheter, Pronto V3 Extraction Catheter, and FETCH Aspiration Catheter.

## Supporting Information

Preclinical animal testing supported the substantial equivalency of the FETCH Aspiration Catheter to the predicate device for the indicated use.