Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80

K260499 · ABBOTT MEDICAL · DQY · Mar 13, 2026 · Cardiovascular

Device Facts

• Record ID: K260499
• Device Name: Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
• Applicant: ABBOTT MEDICAL
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 13, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Amplatzer™ Trevisio™ Intravascular Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

Device Story

Intravascular delivery system; provides pathway for introduction of Amplatzer occluders (e.g., septal, PFO, muscular VSD occluders) into cardiac chambers, coronary vasculature, or peripheral vasculature. System comprises sheath, dilator, delivery cable, loader, and cable vise. Used by physicians in clinical settings; facilitates precise placement of occluder devices. Operates via manual manipulation of delivery components to navigate vasculature. Output is the successful delivery and deployment of the occluder device. Benefits include minimally invasive access for structural heart and vascular interventions.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), dimensional analysis, system leak testing, tensile strength, luer compliance, and packaging verification (ASTM F2825, D4332, D4169). Sterilization validated to SAL 10^-6 per ISO 11135.

Technological Characteristics

Percutaneous catheter delivery system. Components: sheath, dilator, delivery cable, loader, cable vise. Materials evaluated per ISO 10993-1 and ASTM F2475. Sterilization: Ethylene Oxide (EO) gas (ISO 11135). Single-use. Mechanical delivery mechanism; no electronic or software components.

Indications for Use

Indicated for patients requiring a pathway for the introduction of devices into the cardiac chambers, coronary vasculature, or peripheral vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Amplatzer™ Trevisio™ Intravascular Delivery System (K190581)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 13, 2026

Abbott Medical
Meghann Kayoum
Senior Regulatory Affairs Specialist
177 County Rd. B E.
St. Paul, Minnesota 55117

Re: K260499
Trade/Device Name: Amplatzer™ Trevisio™ Intravascular Delivery System;
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: DQY
Dated: February 13, 2026
Received: February 13, 2026

Dear Meghann Kayoum:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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K260499 - Meghann Kayoum
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the Medical Device File (21 CFR 820.181).

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K260499 - Meghann Kayoum
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jenny R. Katsnelson -S
Digitally signed by Jenny R. Katsnelson -S
Date: 2026.03.13 10:49:27 -04'00'

for Lydia Glaw
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

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K260499 | |
| Device Name Amplatzer Trevisio Intravascular Delivery System | |
| Indications for Use (Describe) The Amplatzer™ Trevisio™ Intravascular Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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K260499

Abbott

Amplatzer™ Trevisio™ Intravascular Delivery System

Special 510(k)

# 510(k) SUMMARY

The 510(k) summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

## I. SUBMITTER INFORMATION

Submitter Name Abbott Medical
Submitter Address 177 County Road B East
St. Paul, MN 55117 USA
Phone [phone]
Contact Person Meghann Kayoum
Date Prepared 13 February 2026

## II. DEVICE

Name of Device Amplatzer™ Trevisio™ Intravascular Delivery System
Common Name Catheter Delivery Sheath
Classification Name Catheter, Percutaneous (21 CFR 870.1250)
Device Class II
Product Code DQY

## III. PREDICATE DEVICES

Predicate: Amplatzer™ Trevisio™ Intravascular Delivery System (K190581, cleared on April 5, 2019).

## IV. DEVICE DESCRIPTION

The Amplatzer Trevisio Intravascular Delivery System is designed to deliver Amplatzer Occluders including Amplatzer Septal Occluder (ASO), Amplatzer Multifenestrated Septal Occluder - "Cribriform," Amplatzer™ PFO Occluder, Amplatzer Muscular VSD Occluder and the Amplatzer P.I. Muscular VSD Occluder. The occluder and delivery system are shipped separately.

## V. INDICATIONS FOR USE

The Amplatzer™ Trevisio™ Intravascular Delivery System is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The Amplatzer Trevisio Intravascular Delivery System incorporates substantially equivalent design, function, packaging, sterilization process, materials, fundamental technology, indication for use, and operating principles as those shared by the predicate Amplatzer Trevisio Intravascular Delivery System (K190581).

A comparison of the predicate and subject devices shows they have substantially equivalent design characteristics, including identical sheath, dilator, delivery cable, loader and cable vise components provided with the device. The differences between the predicate and subject device are in the hemostasis valve component which involves removal of an adapter, geometry updates, and material changes. The differences have been demonstrated to be substantially equivalent to the predicate. The similarities in components provide a similar user interface with the device, and the same principles of operation are used to achieve the intended use.

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K260499

Abbott

Amplatzer™ Trevisio™ Intravascular Delivery System

Special 510(k)

# 510(k) SUMMARY

## VII. PERFORMANCE DATA

The following testing was provided in support of a substantial equivalence determination.

## Biocompatibility

A biocompatibility evaluation was conducted in accordance with the FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2023), ISO 10993-1, ISO 14971 and ASTM F2475. Evaluation was conducted in the following categories:

- Hemocompatibility
- Cytotoxicity
- Sensitization
- Irritation
- Materials-Mediated Pyrogenicity
- Acute Systemic Toxicity
- Particulate Evaluation

All established acceptance criteria were met for these tests, demonstrating the Amplatzer Trevisio Intravascular Delivery System is biocompatible for its intended use.

## Design Verification

Non-clinical bench testing was conducted to demonstrate the changes to the Amplatzer Trevisio Intravascular Delivery System met all product specifications through a shelf life of 3 years, including:

- Dimensional
- System Leak
- Tensile Strength
- Luer Compliance

## Sterilization

The Amplatzer Trevisio Intravascular Delivery System is intended for single use only and is provided sterile via ethylene oxide (EO) gas to achieve a Sterility Assurance Level (SAL) of $10^{-6}$ per ISO 11135. An EO/ECH residuals and comparative resistance assessment found the changes did not impact the residuals or ability to achieve a SAL of $10^{-6}$ compared to the predicate device.

## Packaging

Packaging verification studies were performed in compliance with the applicable requirements of ASTM F2825, ASTM D4332, and ASTM D4169. All device packaging met acceptance criteria following sterilization, environmental conditioning and transport simulation.

## VIII. CONCLUSION

Based on the indication for use, technological characteristics and non-clinical performance testing provided, the subject Amplatzer Trevisio Intravascular Delivery System is substantially equivalent to the predicate Amplatzer Trevisio Intravascular Delivery System (K190581). The Amplatzer Trevisio Intravascular Delivery System should perform as intended in the specified use conditions.