PerQseal Introducers

K252309 · Vivasure Medical Limited · DYB · Oct 23, 2025 · Cardiovascular

Device Facts

• Record ID: K252309
• Device Name: PerQseal Introducers
• Applicant: Vivasure Medical Limited
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 23, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

PerQseal Introducer: The PerQseal Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature. PerQseal Elite Introducer: The PerQseal Elite Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

Device Story

PerQseal Introducers (S, L, Elite 14F, 18F) consist of an introducer sheath and a dilator. The device provides a conduit for inserting diagnostic or endovascular tools into femoral vasculature. The dilator guides the sheath to the access site and provides a blood signal to confirm proper positioning. Used in clinical settings by healthcare professionals. The device features a silicone hemostatic valve to minimize blood loss. Benefits include atraumatic tracking through vasculature and reliable access for endovascular procedures.

Clinical Evidence

Bench testing only. Testing included cannula insertion, coating presence, accessory compatibility, blood signal verification, surface/visual inspection, dimensional analysis, tensile strength, leak testing, and lubricity. Biocompatibility testing (cytotoxicity, sensitization, irritation, hemocompatibility, pyrogenicity, toxicity) and sterility/shelf-life (ASTM F1980) were performed. Animal studies assessed usability, compatibility, bleeding control, and site re-access.

Technological Characteristics

Materials: Dilator (LDPE, BaSO4), Sheath (HDPE, Orevac, Pebax, encapsulated stainless steel coil). Features: Hydrophilic coating, silicone hemostatic valve, radiopaque dilator and sheath tip. Dimensions: 14F and 18F diameters, 15 cm effective length. Compatibility: 0.035" guidewire. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for patients requiring femoral vascular access for the insertion of diagnostic or endovascular devices.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Sentrant Introducer Sheath with Hydrophilic Coating (K171866)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

October 23, 2025

Vivasure Medical Limited
% Fernando Aguel
Vice President, Heart Failure & Circulatory Support Regulatory Affairs
MCRA LLC
803 7th Street, NW
3rd Floor
Washington, District of Columbia 20001

Re: K252309
Trade/Device Name: PerQseal Introducers
Regulation Number: 21 CFR 870.1340
Regulation Name: Catheter introducer
Regulatory Class: Class II
Product Code: DYB
Dated: July 24, 2025
Received: July 24, 2025

Dear Fernando Aguel:

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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (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 systems (QS) regulation (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

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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-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,

MISTI L. MALONE -S

Misti Malone, PhD
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) K252309 | |
| Device Name PerQseal Introducers | |
| Indications for Use (Describe) PerQseal Introducer: The PerQseal Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature. PerQseal Elite Introducer: The PerQseal Elite Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral 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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510(k) Summary

Device Trade Name: PerQseal Introducers

Manufacturer: Vivasure Medical Limited
Parkmore Business Park West
West Galway, Co. Galway, Ireland
H91 V3KP

Prepared by: MCRA, an IQVIA Business
803 7th Street, NW, 3rd Floor
Washington, DC 20001
Office: 202.552.5800

Date Prepared: July 24, 2025

Classifications: 21 CFR 870.1340

Class: II

Product Codes: DYB

Primary Predicate: Sentrant Introducer Sheath with Hydrophilic Coating (Medtronic, K171866)

Indications For Use:

PerQseal Introducer: The PerQseal Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

PerQseal Elite Introducer: The PerQseal Elite Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

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# Device Description

Each PerQseal Introducer ('S', 'L', Elite 14F, and Elite 18F) includes an Introducer Sheath with a Dilator positioned within the lumen. The Introducer Sheath comprises a simple sheath that provides access to the site, while the Dilator is a component which guides the Introducer Sheath to the access site and provides a blood signal that is used to ensure proper positioning of the Introducer Sheath.

# Predicate Device:

The purpose of this Traditional 510(k) is to demonstrate that the PerQseal Introducers are substantially equivalent to predicate device for the purpose of introducing the system to interstate commerce. It has been determined that the PerQseal Introducers are substantially equivalent to the following predicate:

- Primary Predicate: Sentrant Introducer Sheath with Hydrophilic Coating (Medtronic, K171866)

| | Subject Device | Primary Predicate |
| --- | --- | --- |
| Device Name | PerQseal Introducers | Sentrant Introducer Sheath with Hydrophilic Coating |
| K Number | N/A | K171866 |
| Manufacturer | Vivasure Medical Limited | Medtronic Vascular, Inc. |
| Product Code | DYB | DYB |
| Indications | PerQseal Introducer: The PerQseal Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.
PerQseal Elite Introducer: The PerQseal Elite Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature. | The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions. |
| Intended Use | Introduction of endovascular devices into patient vasculature | Introduction of endovascular devices into patient vasculature |

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| | Subject Device | Primary Predicate |
| --- | --- | --- |
| Device Name | PerQseal Introducers | Sentrant Introducer Sheath with Hydrophilic Coating |
| Image | | |
| Condition of Use | Single Use | Singe Use |
| Sheath Diameters | 14 Fr
18 Fr | 12 Fr to 26 Fr (2 Fr Increments) |
| Sheath Working Length | Effective Length 15 cm | 28cm – 64cm |
| Guidewire Compatibility | 0.035” | 0.035” |
| Hydrophilic Coating | Yes | Yes |
| Radiopacity | The dilator is radiopaque and has a flexible tapered tip that facilitates atraumatic tracking through the vasculature.
Sheath - Radiopaque Tip | Dilator – Fully Radiopaque
Sheath – Marker Band at Tip |
| Hemostasis Technology | Silicone Seal (Hemostatic Valve) | Silicone Seals |
| Device Materials | Dilator: LDPE, BaSO4
Sheath: HDPE, Orevac and Pebax, encapsulated stainless steel coil | Dilator: HDPE or HDPE/LDPE Blend, BaSO4
Sheath: Composite structure composed of HDPE, Orevac and Pebax with an encapsulated stainless steel coil |
| Sterility | Sterile to the SAL of 10^{-6} | Sterile to the SAL of 10^{-6} |

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| | Subject Device | Primary Predicate |
| --- | --- | --- |
| Device Name | PerQseal Introducers | Sentrant Introducer Sheath with Hydrophilic Coating |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Shelf Life | 12 months | 24 months |

# Performance Testing Summary:

The following bench testing has been conducted on the PerQseal Introducers:

- Cannula Insertion
- Coating Presence
- Compatibility with Accessories
- Device Blood Signal
- Device Surface
- Device Visualization
- Dilator Distal Inner Diameter
- Dilator Effective Length
- Dilator Guidewire Compatibility
- Dilator Hub Inner Diameter
- Dilator Hub Tensile
- Dilator Shaft Outer Diameter
- Dilator Taper Length
- Dilator Visual
- Introducer - Slip
- Lubricity
- Sheath Effective Length
- Sheath Hub Tensile
- Sheath Leak – No Valve
- Sheath Shaft Inner Diameter
- Sheath Shaft Outer Diameter
- Sheath Shaft to Tip Tensile
- Sheath Sidearm to Hub Tensile
- Sheath Sidearm to Stopcock Tensile
- Sheath Tip Inner Diameter
- Sheath Valve Leak
- Sheath Visual
- Biocompatibility, including:
- Cytotoxicity
- Sensitization

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- Irritation
- Hemocompatibility
- Material Mediated Pyrogenicity
- Acute Systemic Toxicity

- Sterility, including
- EO/ECH Residuals
- Bioburden
- Bacterial Endotoxins
- Bacteriostasis and Fungistasis (B&F)
- Product Sterility

- Shelf-Life to 12 months (per ASTM F1980)

- Animal Studies, to assess:
- Device Usability
- Device Compatibility
- Performance (Bleeding control)
- Site Re-access

## Substantial Equivalence:

The subject device was demonstrated to be substantially equivalent to the predicate cited above with respect to indications, design materials, function, manufacturing, and performance. The non-clinical tests performed by the company demonstrated that the PerQseal Introducers are able to withstand physiological loading and is substantially equivalent to the predicate device.

## Conclusion:

The subject device and the predicate device have the same intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate device listed above. The PerQseal Introducers are as safe, as effective, and performs as well as, or better, than the predicate devices.