(31 days)
The ProtekDilate Vascular Access Kits are intended for single use by a trained physician to assist in vessel cannulation.
The subject device ProtekDilate Vascular Access Kits are intended for single use by a trained physician to assist in vessel cannulation. The subject device kits are comprised of eight (8) vascular dilators with diameters of 8/10, 14, 16, 18, 22, 26, 28, and 30 Fr. The dilators are designed to accept 0.035" and 0.038" guidewires and consists of hubs comprised of ABS. Additional kit components include a #11 scalpel, 18 GA Seldinger type echogenic introducer needle, 10 cc syringe, and two 0.035" or 0.038" guidewires. All kit components, including the 8/10 Fr dilator (8/10 Two Stage Dilator, K162389), are off-the-shelf with the exception of the 14-30 Fr dilators, which will be manufactured by Sorin Group Italia S.R.L..
The ProtekDilate Vascular Access Kits are sterile, non-pyrogenic devices for single use only, and are not to be re-sterilized by the user.
N/A
FDA 510(k) Clearance Letter - ProtekDilate Vascular Access Kit
Page 1
Sorin Group Italia S.R.L.
℅ Jennifer Houck
Principal Regulatory Affairs Specialist
Liva Nova Usa, Inc.
14401 W. 65th Way
Arvada, Colorado 80004
Re: K253616
Trade/Device Name: ProtekDilate Vascular Access Kit
Regulation Number: 21 CFR 870.1310
Regulation Name: Vessel dilator for percutaneous catheterization
Regulatory Class: Class II
Product Code: DRE
Dated: November 17, 2025
Received: November 18, 2025
Dear Jennifer Houck:
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.
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"
December 19, 2025
Page 2
U.S. FOOD & DRUG ADMINISTRATION
December 19, 2025
℅ Jennifer Houck
Principal Regulatory Affairs Specialist
Liva Nova Usa, Inc.
14401 W. 65th Way
Arvada, Colorado 80004
Re: K253616
Trade/Device Name: ProtekDilate Vascular Access Kit
Regulation Number: 21 CFR 870.1310
Regulation Name: Vessel dilator for percutaneous catheterization
Regulatory Class: Class II
Product Code: DRE
Dated: November 17, 2025
Received: November 18, 2025
Dear Jennifer Houck:
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.
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"
K253616 - Jennifer Houck Page 2
(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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
K253616 - Jennifer Houck Page 3
Sincerely,
FINN E. DONALDSON -S
Digitally signed by FINN E. DONALDSON -S
Date: 2025.12.19 14:33:52 -05'00'
Finn Donaldson
Acting 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
Page 4
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): K253616
Device Name: ProtekDilate Vascular Access Kit
Indications for Use (Describe)
The ProtekDilate Vascular Access Kits are intended for single use by a trained physician to assist in vessel cannulation.
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
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"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 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary
(in accordance with 21 CFR 807.92)
K253616
Page 1 of 3
I. Applicant Information
Applicant:
SORIN GROUP ITALIA S.R.L.
Via Statale 12 Nord, 86
Mirandola, MO 41037 Italy
Contact Person: Luigi Vecchi
Director, Regulatory Affairs – CP Disposables
Tel: +39 0592 29957
e-mail: luigi.vecchi@livanova.com
Application Correspondent:
LIVANOVA USA INC
14401 West 65th Way
Arvada, CO 80004
Contact Person: Jennifer Houck
Principal Regulatory Affairs Specialist
Tel: 717 383 8558
e-mail: jennifer.houck@livanova.com
Date Prepared: December 18th 2025
II. Subject Device Identification
Device Trade Name: ProtekDilate Vascular Access Kit
510(k) Number: K253616
Classification Name: Dilator, Vessel, For Percutaneous Catheterization
Regulation Number: 21 CFR 870.1310
Product Code: DRE
Classification: Class II
Classification Panel: Cardiovascular
Page 6
K253616
Page 2 of 3
III. Predicate Device
The ProtekDilate Vascular Access Kits are substantially equivalent to the following cleared predicate device. The subject device and predicate device have the same fundamental scientific technology and intended use:
| Predicate Device | Reference Device |
|---|---|
| ProtekDuo Venous Dilator Set | MC3 Vascular Access Kit 21030 |
| 510(k) Number: K162181 | 510(k) Number: K182914 |
| Device Trade Name: ProtekDuo Venous Dilator Set (14 Fr to 26 Fr) | Device Trade Name: MC3 Vascular Access Kit 21030 |
| Classification Name: Dilator, Vessel, for Percutaneous Catheterization | Classification Name: Dilator, Vessel, for Percutaneous Catheterization |
| Regulation Number: 21 CFR 870.1310 | Regulation Number: 21 CFR 870.1310 |
| Product Code: DRE | Product Code: DRE |
| Classification: Class II | Classification: Class II |
| Classification Panel: Cardiovascular | Classification Panel: Cardiovascular |
IV. Device Description
The subject device ProtekDilate Vascular Access Kits are intended for single use by a trained physician to assist in vessel cannulation. The subject device kits are comprised of eight (8) vascular dilators with diameters of 8/10, 14, 16, 18, 22, 26, 28, and 30 Fr. The dilators are designed to accept 0.035" and 0.038" guidewires and consists of hubs comprised of ABS. Additional kit components include a #11 scalpel, 18 GA Seldinger type echogenic introducer needle, 10 cc syringe, and two 0.035" or 0.038" guidewires. All kit components, including the 8/10 Fr dilator (8/10 Two Stage Dilator, K162389), are off-the-shelf with the exception of the 14-30 Fr dilators, which will be manufactured by Sorin Group Italia S.R.L..
The ProtekDilate Vascular Access Kits are sterile, non-pyrogenic devices for single use only, and are not to be re-sterilized by the user.
V. Indications for Use
The ProtekDilate Vascular Access Kits are intended for single use by a trained physician to assist in vessel cannulation.
VI. Comparison to the Predicate Device
The subject device (ProtekDilate Vascular Access Kits) is identical to the predicate (ProtekDuo Venous Dilator Set), with respect to device technology, principle of operation, sterilization method, and shelf-life. There were minor modifications which incorporated (1) addition of dilator sizes 8/10, 16, 28, and 30 Fr, (2) an increase in dilator durometer from 90A to 95A, (3) modifications made to the dilator hub material from PVC to ABS, and (4) an update to the dilator packaging from pouch to a tray configuration.
VII. Non-Clinical Performance Data
Page 7
K253616
Page 3 of 3
The Subject Device ProtekDilate Vascular Access Kits underwent Verification and Validation activities to address the modifications made since clearance of the Predicate Device ProtekDuo Venous Dilator Set (14 Fr to 26 Fr). These activities are outlined below:
- Deflection Testing
- Pull/Tensile Testing
- Sterilization
- Shelf Life
- Package Integrity
- Biocompatibility
- Cytotoxicity
- Hemocompatibility
The Subject Device ProtekDilate Vascular Access Kits met the acceptance criteria identified in the non-clinical performance testing and demonstrated the device is substantially equivalent to the predicate device.
VIII. Statement of Substantial Equivalence
Based on equivalent intended use and technological characteristics the ProtekDilate Vascular Access Kits can be deemed to be substantially equivalent to their predicate device (ProtekDuo Venous Dilator Set (14 Fr to 26 Fr), K162181) and reference device (MC3 Vascular Access Kit 21030, K182914).
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).