Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
Device Facts
| Record ID | K261825 |
|---|---|
| Device Name | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter |
| Applicant | Abbott |
| Product Code | DQY · Cardiovascular |
| Decision Date | Jul 2, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Indications for Use
The Amplatzer TorqVue LP 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. The Amplatzer TorqVue LP Catheter 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
Percutaneous catheter delivery system; facilitates attachment, loading, delivery, and deployment of occluders. Components include delivery catheter, loader, hemostasis valve with extension tube/stopcock, plastic vise, and delivery wire. Available in 4 Fr or 5 Fr sizes with 90-degree curves and 60 cm or 80 cm lengths. Used by clinicians in clinical settings to provide a pathway for interventional devices. Operates via manual insertion and navigation through vasculature. Output is a stable pathway for device delivery; enables minimally invasive cardiac or peripheral procedures. Benefits include precise, controlled delivery of occluder devices.
Clinical Evidence
No clinical data. Evidence consists of non-clinical bench testing, including biocompatibility (ISO 10993-1), dimensional analysis, system leak, 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; ethylene oxide sterilized (ISO 11135); single-use. Materials evaluated per ISO 10993-1, ISO 14971, and ASTM F2475. Features hemostasis valve, loader, and delivery wire. 4 Fr/5 Fr sizes; 60 cm/80 cm lengths. Mechanical navigation principle.
Indications for Use
Indicated for patients requiring a pathway for the introduction of devices into the heart 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
Submission Summary (Full Text)
{0}
**U.S. FOOD & DRUG**
ADMINISTRATION
July 2, 2026
Abbott
Maddie Cook
Regulatory Affairs Specialist II
177 County Rd. B E.
Saint Paul, Minnesota 55117
Re: K261825
Trade/Device Name: Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous catheter
Regulatory Class: Class II
Product Code: DQY
Dated: June 1, 2026
Received: June 2, 2026
Dear Maddie Cook:
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.
{1}
K261825 - Maddie Cook
Page 2
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), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (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 ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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
{2}
K261825 - Maddie Cook
Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LYDIA S. GLAW -S
Digitally signed by
LYDIA S. GLAW -S
Date: 2026.07.02
12:52:22 -04'00'
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
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# **Indications for Use**
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K261825
Device Name
Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
Indications for Use (Describe)
The Amplatzer TorqVue LP 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.
The Amplatzer TorqVue LP Catheter 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
PRAStaff@fda.hhs.gov
*"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."*
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
{4}
K261825
Page 1 of 3
Abbott
Amplatzer™ TorqVue™ LP Delivery System
Amplatzer™ TorqVue™ LP Catheter
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 | (651) 756-3528 |
| Contact Person | Maddie Cook |
| Date Prepared | June 1, 2026 |
# II. DEVICE
| Name of Device | Amplatzer™ TorqVue™ LP Delivery System Amplatzer™ TorqVue™ LP Catheter |
| --- | --- |
| Common Name | Catheter Delivery Sheath |
| Classification Name | Catheter, Percutaneous (21 CFR 870.1250) |
| Device Class | II |
| Product Code | DQY |
# III. PREDICATE DEVICES
Primary Predicates:
- Amplatzer™ TorqVue™ LP Delivery System (K131063, cleared August 15, 2013).
- Amplatzer™ TorqVue™ LP Catheter (K162228, cleared April 5, 2019)
# IV. DEVICE DESCRIPTION
The Amplatzer TorqVue LP Delivery System consists of a delivery catheter, loader, hemostasis valve with extension tube and stopcock, plastic vise, and delivery wire. The delivery system was designed to facilitate attachment, loading, delivery, and deployment of an occluder. The Amplatzer TorqVue LP Delivery System is available in four configurations based on the French size and usable length of the sheath. The delivery system is available in 4 Fr or 5 Fr with a 90-degree (°) curve and usable sheath lengths of 60 centimeters (cm) or 80 cm.
The Amplatzer™ TorqVue™ LP Catheter is designed to provide a pathway through which an occluder may be delivered. The Amplatzer™ TorqVue™ LP Catheter consists of a catheter, loader, hemostasis valve with extension tube and stopcock, and self-sealing hemostasis valve. The Amplatzer™ TorqVue™ LP Catheter is available in a 4 Fr size with a 90-degree (°) curve and a usable length of 80 cm.
# V. INDICATIONS FOR USE
The Amplatzer TorqVue LP 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.
The Amplatzer TorqVue LP Catheter 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 TorqVue LP Delivery System and The Amplatzer TorqVue LP Catheter incorporate substantially equivalent design, function, packaging, sterilization process,
{5}
K261825
Page 2 of 3
Abbott
Amplatzer™ TorqVue™ LP Delivery System
Amplatzer™ TorqVue™ LP Catheter
Special 510(k)
### 510(k) SUMMARY
materials, fundamental technology, indication for use, and operating principles as those shared by the predicate Amplatzer TorqVue LP Delivery System (K131063) and Amplatzer TorqVue LP Catheter (K162228).
A comparison of the predicate and subject devices shows they have substantially equivalent design characteristics, including identical delivery catheter, loader, plastic vise, and delivery wire 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 and with the self-sealing hemostasis valve which involves geometry updates. 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.
### VII. PEFORMANCE 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 TorqVue LP Delivery System and the Amplatzer TorqVue LP Catheter is biocompatible for its intended use.
#### Design Verification
Non-clinical bench testing was conducted to demonstrate the changes to the Amplatzer TorqVue LP Delivery System and the Amplatzer TorqVue LP Catheter met all product specifications through a shelf life of 3 years, including:
- Dimensional
- System Leak
- Tensile Strength
- Luer Compliance
#### Sterilization
The Amplatzer TorqVue LP Delivery System and the Amplatzer TorqVue LP Catheter are 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
{6}
K261825
Page 3 of 3
Abbott
Amplatzer™ TorqVue™ LP Delivery System
Amplatzer™ TorqVue™ LP Catheter
Special 510(k)
### 510(k) SUMMARY
ability to achieve a SAL of 10⁻⁶ compared to the predicate devices.
# 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 TorqVue LP Delivery System is substantially equivalent to the predicate Amplatzer TorqVue LP Delivery System (K131063) and the subject Amplatzer TorqVue LP Catheter is substantially equivalent to the predicate Amplatzer TorqVue LP Catheter (K162228). The Amplatzer TorqVue LP Delivery System and the Amplatzer TorqVue LP Catheter should perform as intended in the specified use conditions.
