MODIFICATION TO: EXPORT CATHETER

K050139 · Medtronic Vascular · QEZ · Mar 22, 2005 · Cardiovascular

Device Facts

• Record ID: K050139
• Device Name: MODIFICATION TO: EXPORT CATHETER
• Applicant: Medtronic Vascular
• Product Code: QEZ · Cardiovascular
• Decision Date: Mar 22, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Export Aspiration Catheter is dual-lumen catheter; designed for embolectomy and infusion. Features continuous aspiration/infusion lumen and distal guidewire lumen for 0.014-inch guidewire compatibility (single-operator design). Operated by physicians in clinical settings. Aspiration syringe and line attach to proximal end to evacuate blood and debris from target site. Device facilitates removal of embolic material or delivery of agents to specific arterial locations. Benefits include clearing arterial obstructions and targeted therapeutic delivery.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Dual-lumen catheter; 7-French size. Materials and manufacturing processes identical to predicate 6-French device. Features aspiration/infusion lumen and distal guidewire lumen for 0.014-inch guidewire. Includes aspiration syringe and line. Non-powered, mechanical device.

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

• Medtronic Export Catheter (K040869)

Submission Summary (Full Text)

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October 8, 2021

Medtronic Vascular Fred Boucher Director, RA 37a Cherry Hill Dr. Danvers, Massachusetts 01923

Re: K050139

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

Dear Fred Boucher:

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 March 22, 2005. 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(a)FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.10.08 10:32:56 -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

MAR 2 2 2005

Medtronic Vascular c/o Mr. Fred L. Boucher Director, Regulatory Affairs 37A Cherry Hill Drive Danvers, MA 01923

K050139 Re: Export Aspiration Catheter Regulation Number: 21 CFR 870.5051 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: 74 DXE Dated: February 23, 2005 Received: February 25, 2005

Dear Mr. Boucher:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premained instantially equivalent (for the indications referenced above and nave decemined the are are and the Madical Devices marketed in interstate for use stated in the enclosure) to regally manced promotion Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chacinone with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provel annlication (PM devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval or answere arcasions of the Act. The and Cosmetic Act (Act) that do not require approvate controls provisions of the Act. The Y ou may, therefore, market the device, becjoc, be use of the manual registration, listing of
general controls provisions of the Act include requirements michrending and general controls provisions of the Fect merides sand prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controlis. Extronize - Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 agai be found in the Code of Pederal Regaring your device in the Federal Register.

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Page 2 -- Mr. Fred L. Boucher

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substantal oquirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a determination that your areas by other Federal agencies. You must or any Federal statutes and regulations administers, but not lited to: registration and listing (21 comply with all the Act s requirements, including, our not and if englise requirements as set
CFR Part 807); labeling (21 CFR Part 801); go a manufacturing practice the elect CFR Part 807); labeling (21 CFR Part 800); good manata 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Party); 11 CFR 1000 1050 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Sections 991 - 12 - 12 - 12 - 12 - 10 -This letter will allow you to begil marketing your artial equivalence of your device to a legally premarket notification. The PDA miding of substantial equive and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific advice for your de not on on on one note the regulation entitled, which and contact the Office of Complance at (210 m/16cation" (21CFR Part 807.97). You may obtain " Misoranding by relected to premation in the Act from the Division of Small other general Informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International Consanhibition www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Xuna R. Winer

Image /page/2/Picture/5 description: The image contains a handwritten symbol that appears to be a combination of a circle and a stylized letter 'B'. The symbol is accompanied by the words 'Branch' and 'Directly' stacked vertically to the right of the symbol. The handwriting is simple and clear, suggesting a note or label.

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):

Device Name: Export Aspiration Catheter

Indications For Use:

The Export Aspiration Catheter is indicated for:

- · Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- · To subselectively infuse/deliver diagnostic 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Duina R. Vachner

· )ivision Sign-Off) Avision of Cardiovascular Devices

10(k) Number K050139

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## MAR 2 2 2005

## Section 7 Summary of Safety and Effectiveness

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 510(R) SOMINARY - 12, Safe Medical Devices Act of 1990)

### Identifying Information: 1.

| 1.1. | Submitters Name: | Medtronic Vascular, Inc.<br>37A Cherry Hill Drive<br>Danvers, MA 01923 |
|------|----------------------------|------------------------------------------------------------------------|
| 1.2. | Contact Person: | Fred L. Boucher R.A.C.<br>[phone] |
| 2. | Classification Name: | Embolectomy Catheter<br>(21 CFR Part 870.5150) |
| 3. | Proprietary Name: | Export Catheter |
| 4. | Name of Predicate Devices: | Medtronic Export Catheter (K040869) |

### Description: 5.

The Export Catheter is a dual lumen catheter for use as a general embolectomy The main (continuous) lumen of the catheter is the aspiration/infusion catheter. lumen while the smaller of the lumens is the guidewire lumen. The size of the wire lumen is sized so that the Export catheter may run over a 0.14-inch guidewire smoothly. Also, the wire lumen is designed as a single operator lumen, as such it is only present on a small section of the distal end of the catheter. The larger sized lumen is the aspiration lumen. An aspiration syringe is provided, as is an aspiration line. These are attached to the proximal end of the Export to facilitate blood and debris being evacuated from the site into the syringe.

#### Intended-Use: 6.

The Export Catheter is designed as an aspiration catheter. The 7-French Export Catheter has identical indications for use as the 6-French Export Catheter, the legally marketed predicate device.

The indication for use of the Export catheter is presented here.

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The Export Aspiration Catheter is indicated for:

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

#### Technology: 7.

The 7-French Export Catheter is manufactured in the same manner, using the same processes and materials, as the 6-French Export Catheter, a legally marketed predicate device. In addition to being technologically equivalent to the predicate devices, the 7-French Export Catheter has been subjected to performance testing and it has been determined that the Export Catheter is suitable for its intended use.