MEDTRONIC EXPORT AP CATHETER

K081573 · Medtronic Vascular · DXE · Jun 27, 2008 · Cardiovascular

Device Facts

• Record ID: K081573
• Device Name: MEDTRONIC EXPORT AP CATHETER
• Applicant: Medtronic Vascular
• Product Code: DXE · Cardiovascular
• Decision Date: Jun 27, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic Export® AP Catheter is indicated for: - Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and - To subselectively infuse/deliver diagnostics or therapeutic agents with or without vessel occlusion

Device Story

Dual-lumen aspiration catheter; used for removal of thrombus/debris from arterial vessels; secondary use for subselective infusion of diagnostic/therapeutic agents. Features distal dual-lumen design: smaller lumen for 0.014" guidewire tracking; larger lumen for aspiration. Includes radiopaque markerband for fluoroscopic visualization; lubricious external coating; wire-braided shaft for stiffness/compliance balance; luer hub for aspiration line connection. Operated by physicians in clinical/interventional settings. Device facilitates mechanical removal of obstructions and targeted drug delivery; improves procedural outcomes by restoring vessel patency.

Clinical Evidence

Bench testing only. No clinical data provided. Device passed all design verification and validation testing.

Technological Characteristics

Dual-lumen catheter; wire-braided shaft; radiopaque markerband; lubricious external coating; luer hub connection. Compatible with 0.014" guidewires. Mechanical device; no energy source or software.

Indications for Use

Indicated for removal/aspiration of embolic material (thrombus/debris) from the arterial system and subselective infusion/delivery of diagnostic or therapeutic agents in patients requiring vascular intervention.

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

• Medtronic Export® XT Aspiration Catheter (K061958)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".

May 20, 2021

Medtronic Vascular Tara Turney Regulatory Affairs Specialist 37a Cherry Hill Drive Danvers, Massachusetts 01923

Re: K081573

Trade/Device Name: Medtronic Export AP Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Tara Turney:

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 June 27, 2008. 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: 2021.05.20

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

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2008

Medtronic Vascular c/o Ms. Tara N. Turney Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923-5186

Re: K081573

Trade Name: Medtronic Export® AP Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: June 4, 2008 Received: June 5, 2008

Dear Ms. Turney:

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

{2}------------------------------------------------

Page 2 - Ms. Tara N. Turney

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 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) 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. Vachner

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

Enclosure

{3}------------------------------------------------

## Indications for Use

K68573 510(k) Number (if known):

Device Name: Medtronic Export® AP Catheter -

Indications for Use:

The Medtronic Export® AP Catheter is indicated for:

- Removal/aspiration of embolic material (thrombus/debris) from vessels of 0 the arterial system, and
- To subselectively infuse/deliver diagnostics or therapeutic agents with or � without vessel occlusion

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Sochmer

(Division Sign-Off) Division of Cardiovascular Devices Page 1 of

510(k) Number_K081593

Page 88

{4}------------------------------------------------

081573

## JUN 27 2008 510(k) Summary Submitter: Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923-5186 Contact Person: Tara N. Turney Regulatory Affairs Specialist Phone: [phone] Fax: [phone] [e-mail] June 4th, 2008 Date Prepared: Trade Name: Medtronic Export® AP Aspiration Catheter Common Name: Aspiration Catheter Classification Embolectomy Catheter Name: Predicate Device: Medtronic Export® XT Aspiration Catheter K061958 Device The Medtronic Export® AP Aspiration Catheter is a dual Description: lumen catheter used for aspiration of thrombus and/or debris from a vascular site. The Medtronic Export® AP may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site. Statement of The Medtronic Export® AP Aspiration Catheter is indicated Intended Use: for: Removal/aspiration of embolic material . (thrombus/debris) from vessels of the arterial system, and . To subselectively infuse/deliver diagnostics or therapeutic agents with or without vessel occlusion. Summary of . Distal Dual Lumen: The smaller of the two lumens Technological provides a conduit for delivery over a 0.014" Characteristics: guidewire, or equivalent, and the larger lumen provides conduit for aspiration of embolic material. . Radiopaque Markerband: Embedded in the distal tip to facilitate placement by fluoroscopy.

{5}------------------------------------------------

- External Coating: Provides lubricious external surface . for ease of delivery. Wire Braided Shaft: Provides a balance of stiffness . and compliance for delivery of the catheter to the intended therapy site. Luer Hub: Provides a connection fitting to mate the . shaft with the aspiration line. The proposed Medtronic Export® AP Aspiration Catheter has Summary of Nonsuccessfully passed all design verification and validation clinical Data: testing. Conclusion from Medtronic has demonstrated that the Export® AP Aspiration Data: Catheter is substantially equivalent to the predicate device based upon indications for use, design, test results and fundamental scientific technology.