DIVER C.E. CATHETER

K050276 · Invatec Innovative Technologies, S.R.L. · QEZ · Mar 7, 2005 · Cardiovascular

Device Facts

• Record ID: K050276
• Device Name: DIVER C.E. CATHETER
• Applicant: Invatec Innovative Technologies, S.R.L.
• Product Code: QEZ · Cardiovascular
• Decision Date: Mar 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Device Story

DIVER C.E. Catheter is an aspiration catheter for removing fresh, soft emboli and thrombi from arterial vessels. Device features a full-length aspiration lumen and a luer lock hub for syringe connection (syringe not provided). Design includes a soft, atraumatic tip with a radiopaque marker band 1mm from the distal end. Available in configurations with or without sideholes. Rapid exchange design with guide wire lumen extending 22.7 cm proximally; compatible with 0.014" guide wires. Used by physicians in clinical settings to aspirate clots via manual syringe suction. Output is the physical removal of thrombus, aiding in vessel recanalization and improving patient blood flow.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 (1997) and FDA Memorandum #G95-1. Performance characteristics compared via bench tests against predicate devices to demonstrate equivalency.

Technological Characteristics

Aspiration catheter with full-length lumen; rapid exchange design; 0.014" guide wire compatibility; radiopaque marker band; available with/without sideholes. Materials demonstrated biocompatible per ISO 10993. No energy source or software.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from arterial system vessels.

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

• Vascular Solutions Pronto™ Extraction Catheter (K032763)
• Invatec Innovative Technologies SUBMARINE PLUS™ PTA Catheter (K042537)
• Invatec Innovative Technologies AMPHIRION DEEP PTA Balloon Catheter (K042624)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 8, 2021

Invatec Innovative Technologies, S.r.l. Patrice Stromberg Senior Regulatory Affairs Specialist 4600 Nathan Lane North Plymouth, Minnesota 55442

Re: K050276

Trade/Device Name: Diver C.E. Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Patrice Stromberg:

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 7, 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(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.10.08 10:34:57 -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

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a series of flowing lines, often interpreted as representing health and well-being.

MAR 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ev3 Inc. c/o Mr. Patrice Stromberg Sr. Regulatory Affairs Specialist 4600 Nathan Lane North Plymouth, MN 55442-2920

Re: K050276

Diver C.E. Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: February 4, 2005 Received: February 7, 2005

Dear Mr. Stromberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 IQC) premainted is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed previce Amendments. for use stated in the enclosure) to legally manced to of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drue, commerce prior to May 28, 1976, the chactinent with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the provisions of the Act. The Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general registration, listing You may, therefore, market the device, subject to the genirst for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mendo requirements 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) into entire) water regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controlis. Existing major to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Poachar Ing your device in the Federal Register.

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Page 2 - Mr. Patrice Stromberg

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 that I Dr has made a acted regulations administered by other Federal agencies. You must of ally I catal statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI N Fat 607), laochig (21 OFR regulation (21 CFR Part 820); and if applicable, the electronic forul in the quanty systems (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) I mis letter with anow you to begin finding of substantial equivalence of your device to a legally prematicated 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 If you desire specific aarioliance 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 other general mionnational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duane R. Virtanen

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): KOSO27 6

DIVER™ C.E. Catheter Device Name:

Indications for Use:

The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Prescription Use (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)

Page 1 of 1

Duane R. Vollmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Kusso 276

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#### MAR 7 - 2005 510(k) Summary DIVERTM C.E. Catheter

510(k) Number: KOSO276

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR \$807.92.

| Submitter/Contact Person:<br>Applicant<br>(Manufacturer): | Invatec Innovative Technologies<br>Via Martiri della Libertà, 7<br>25030 Roncadelle (BS) Italy<br>Tel: [phone]<br>Fax: [phone] |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name: | ev3 Inc.<br>4600 Nathan Lane North<br>Plymouth, MN 55442<br>Tel: [phone]<br>Fax: [phone] |
| Official Contact: | Patrice Stromberg<br>Sr. Regulatory Affairs Specialist<br>ev3 Inc.<br>4600 Nathan Lane North<br>Plymouth, MN 55442<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Summary Preparation Date: | February 4, 2005 |
| Device Name and Classification:<br>Trade Name:<br>Common Name/Usual Name: | DIVERTM C.E. Catheter<br>Catheter, Embolectomy |

Predicate Devices:

Class:

Classification Name:

Vascular Solutions Pronto™ Extraction Catheter (K032763) Invatec Innovative Technologies SUBMARINE PLUS™ PTA Catheter (K042537) Invatec Innovative Technologies AMPHIRION DEEP PTA Balloon Catheter (K042624)

Catheter, Embolectomy

Class II, 21 CFR 870.5150

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### Device Description:

The DIVER C.E. Catheters are aspiration catheters indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. The catheters fresh, son emoved an lumen running through the full length of the catheter. A luer lock type hub in the proximal end allows the connection of a stopcock and a syringe for blood aspiration and clot removal (not provided). The DIVER C.E. Syringe for blood aspiration lumen and a soft, atraumatic tip. The smooth, soft, atraumatic tip has a radiopaque marker band located at 1mm from its distal end. The DIVER C.E. Catheters are available in two configurations, with and with ut sideholes. The catheters are a rapid exchange design, with the guide wire lumen running from the distal tip to 22.7 cm proximally in the catheter body, where the exit port is located. The catheters are compatible with guide wires with a maximum diameter of 0.014".

### Intended Use:

The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

## Summary of Testing:

Biocompatibility. Biocompatibility testing in accordance with ISO 10993, "Biological Evaluation of Medical Devices," 1997(E) and FDA Memorandum #G95-1, "Biological Evaluation of Medical Devices" was provided. The material used in the Invatec DIVER C.E. Catheter has been demonstrated to be biocompatible.

Performance Data: Comparison bench tests regarding performance characteristics were performed on the DIVER C.E. Catheter (with sideholes), DIVER C.E. Catheter (without sideholes), and the predicate devices to demonstrate equivalency.

## Statement of Equivalence:

The DIVER C.E. Catheters are substantially equivalent to the currently marketed Vascular Solutions Pronto™ Extraction Catheter (K032763), Invatec SUBMARINE PLUS™ PTA Catheter (K042537) and Invatec AMPHIRION DEEP™ PTA Balloon Catheter (K042624) in intended use, performance, technological characteristics and materials.