FETCH ASPIRATION CATHETER

K062172 · Possis Medical, Inc. · QEZ · Sep 20, 2006 · Cardiovascular

Device Facts

• Record ID: K062172
• Device Name: FETCH ASPIRATION CATHETER
• Applicant: Possis Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Sep 20, 2006
• 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 2 mm or larger vessels in the arterial system.

Device Story

The FETCH Aspiration Catheter is a rapid exchange, low-profile, dual-lumen catheter designed for manual aspiration of emboli and thrombi. The device tracks to the target site over a 0.014" guidewire and is advanced through a 6F guiding catheter. It includes an extension line, a 30 cc syringe for manual suction, a one-way stopcock, and a 40-micron collection basket for filtering aspirated material. A radiopaque marker at the distal tip assists in positioning. Used by physicians in clinical settings, the device allows for the removal of obstructive material from the arterial system, potentially restoring blood flow. The collection basket enables laboratory analysis of the aspirated thrombus.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench, biocompatibility, animal, packaging, and sterilization testing.

Technological Characteristics

Rapid exchange, dual-lumen catheter; 0.052" outer diameter; 0.014" guidewire compatibility; radiopaque distal marker; manual aspiration via 30 cc syringe; includes 40-micron collection basket. No performance standards developed under Section 514.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from arterial vessels 2 mm or larger.

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)

Submission Summary (Full Text)

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September 15, 2021

Possis Medical, Inc. Frank Freedman Senior Regulatory Affairs Associate 9055 Evergreen Blvd., N.w. Coon Rapids, Minnesota 55433-8003

Re: K062172

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 September 20, 2006. 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,

Digitally signed by Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2021.09.15
09:20:47 -04:00:20:47 -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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SEP 2 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Possis Medical, Inc. c/o Frank B. Freedman, Ph.D. Senior Regulatory Affairs Associate 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003

K062172 Re:

Trade/Device Name: FETCH Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: DXE Dated: September 7, 2006 Received: September 8, 2006

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, 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 agencies. You must

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

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 Of A rate 677) havemes (QS) regulation (21 CFR Part 820); and if applicable, the electronic rorduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control to begin marketing your device as described in your Section 510(k) rms lotter notification. The FDA finding of substantial equivalence of your device to a legally premaince noticated with 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 vours,

Dmna R. Wulner

A 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): |0(c Z 17 2

Device Name: FETCH Aspiration Catheter

Indications For Use: The FETCH™ Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from 2 mm or larger vessels in the arterial system.

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)

Duna R. Vodmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k062172

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Deficiency Response (K062172) FETCH Aspiration Catheter

9/7/2006

#### Appendix 3

| 5.<br>510(k) Summary | | | | | SEP 20 200 | |
|-----------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--|--|------------|--|
| Device Common Name: | Embolectomy Catheter | | | | | |
| Device Trade Name: | FETCH™ Aspiration Catheter | | | | | |
| Device Classification/Name: | Class II<br>21CFR 870.5150<br>Embolectomy Catheter<br>Product Code, DXE | | | | | |
| Manufacturer: | Possis Medical, Inc.<br>9055 Evergreen Boulevard, N.W.<br>Coon Rapids, MN 55433<br>Phone: [phone] | Fax: [phone] | | | | |
| Establishment Registration: | 2183460 | | | | | |
| Submitter: | Frank B. Freedman | | | | | |
| Contact Person: | Primary Contact<br>Frank B. Freedman<br>Possis Medical, Inc. | Secondary Contact<br>Mark D. Stenoien<br>Possis Medical, Inc. | | | | |
| Performance Standards: | No performance standards have been developed under<br>Section 514 for this device. | | | | | |
| Predicate Devices: | Pronto Extraction Catheter (K042937) and other<br>embolectomy catheters | | | | | |

### Device Description

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 45 allows advancement to the target site through a 6F (0.070" I.D.) guiding catherer. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an exterpsion line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This backet can be used to filter aspirated blood for laboratory analysis of collected three " the

## Indications for Use

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

## Supporting Information

Bench, biocompatibility, animal, packaging and sterilization testing supported the substantial equivalency of the FETCH Aspiration Catheter.

#### Conclusion

FETCH is substantially equivalent to the Pronto Extraction Catheter and other embolectomy catheters.

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