MEDTRONIC EXPORT XT CATHETER

K061958 · Medtronic Vascular · QEZ · Sep 5, 2006 · Cardiovascular

Device Facts

• Record ID: K061958
• Device Name: MEDTRONIC EXPORT XT CATHETER
• Applicant: Medtronic Vascular
• Product Code: QEZ · Cardiovascular
• Decision Date: Sep 5, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Dual-lumen catheter for aspiration of thrombus/debris and infusion of diagnostic/therapeutic agents in arterial vasculature; features distal lumen for 0.014" guidewire tracking and large lumen for aspiration; includes radiopaque markerband for fluoroscopic visualization, lubricious external coating, and wire-braided shaft for stiffness/compliance balance; terminates in luer hub with strain relief. Used by physicians in clinical settings (e.g., cath lab) to clear arterial obstructions or deliver localized therapy; provides mechanical aspiration via external vacuum source; benefits patients by restoring blood flow and enabling targeted drug delivery.

Clinical Evidence

Bench testing only. The device successfully passed all design verification and validation testing.

Technological Characteristics

Dual-lumen catheter; wire-braided shaft; radiopaque markerband; lubricious external coating; luer hub with strain relief; 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 arterial vessels and subselective infusion/delivery of diagnostic or therapeutic agents in patients requiring such interventions.

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

• Export Aspiration Catheter (K040869)

Submission Summary (Full Text)

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September 15, 2021

Medtronic Vascular Karen Brozowski RA Manager 37a Cherry Hill Dr. Danvers, Massachusetts 01923

Re: K061958

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

Dear Karen Brozowski:

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 5. 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], [e-mail].

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.09.15
O'connell -S 09:18:24 -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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2006

Medtronic, Inc. c/o Ms. Karen A. Brozowski Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923

Re: K061958 Medtronic® Export® XT Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: August 15, 2006 Received: August 16, 2006

Dear Ms. Brozowski:

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.

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### Page 2 - Ms. Karen A. Brozowski

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); 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.

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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## Indications for Use

510(k) Number (if known): KDG / 958

Device Name: Medtronic Export® XT Catheter

Indications for Use:

::

The Medtronic Export® XT Catheter is indicated for:

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

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

| age 1 of | 1 |
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| 510(k) Number | K061958 |

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# 1061958

## 510(k) Summary

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| Submitter: | Medtronic Vascular<br>37A Cherry Hill Drive<br>Danvers, MA 01923<br>USA | SEP - 5 2006 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Karen A. Brozowski<br>Regulatory Affairs Manager<br>978.739.4143<br>978.777.0390<br>[e-mail] | |
| Date Prepared: | July 7, 2006 | |
| Trade Name: | Medtronic® Export® XT Catheter | |
| Common Name: | Percutaneous Catheter | |
| Classification<br>Name: | Percutaneous Catheter | |
| Predicate Device: | Export Aspiration Catheter (K040869) | |
| Device<br>Description: | The Medtronic Export XT Catheter is a dual lumen catheter<br>used for the aspiration of thrombus and/or debris from a<br>vascular site. The Medtronic Export XT Catheter may also be<br>used for the infusion of diagnostic or therapeutic agents to a<br>desired vascular site. | |
| Statement of<br>Intended Use: | The Medtronic Export XT Catheter is indicated for:<br>Removal/aspiration of embolic material thrombus/debris)<br>from vessels of the arterial system, and to subselectively<br>infuse/deliver diagnostics or therapeutics agents with or<br>without vessel occlusion. | |
| Summary of<br>Technological<br>Characteristics: | • Distal Dual Lumen: Small lumen provides conduit for<br>delivery over a 0.014" guidewire, or equivalent, and large<br>lumen provides conduit for aspiration of embolic material.<br>• Radiopaque Markerband: Embedded in the distal tip to<br>facilitate placement by fluoroscopy<br>• External Coating: Provides lubricious external surface for<br>ease of delivery through the vasculature.<br>• Wire Braided Shaft: Provides a balance of stiffness and<br>compliance for delivery of the catheter to the intended | |

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therapy site.

- Luer Hub: Provides a connection fitting to mate the shaft with the aspiration line.
- · Strain Relief: Provides a stiffness transition between the shaft and the rigid hub to reduce likelihood of shaft kink.

Technological Characteristics (continued):

Summary of

Summary of Nonclinical Data:

The proposed Medtronic Export® XT Catheter has successfully passed all design verification and validation testing.