Peel-Away Introducer Sheath

K254236 · VascuTech Medical, LLC · DYB · Feb 9, 2026 · Cardiovascular

Device Facts

• Record ID: K254236
• Device Name: Peel-Away Introducer Sheath
• Applicant: VascuTech Medical, LLC
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 9, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Peel-Away Introducer Sheath is intended for the percutaneous introduction of catheters and other intravascular devices into the vasculature.

Device Story

Device consists of peelable sheath and dilator; used for percutaneous vascular access. Physician inserts sheath/dilator assembly into vasculature; dilator facilitates entry; sheath provides conduit for catheters or other intravascular devices. Once device is positioned, sheath is peeled away via winged hub, leaving inserted device in place. Used in clinical settings by physicians; single-use, limited duration. Benefits include simplified vascular access and removal of sheath without disturbing placed catheters.

Clinical Evidence

No clinical data. Evidence consists of bench testing and biocompatibility evaluation. Biocompatibility testing (ISO 10993-1:2025) included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, hemolysis, and SC5B-9 complement activation. Performance bench testing included compatibility, leak, dimensional verification, rigidity, integrity, visual inspection, break force, and peel-away testing.

Technological Characteristics

Components: HDPE with 20% BaSO4 and MDPE. Design: Winged hub, cylindrical cannula. Dimensions: 3.5-16F diameter; 5, 7, 10, 13 cm lengths. Sterilization: Ethylene oxide (SAL 10^-6). Single-use, limited duration.

Indications for Use

Indicated for percutaneous introduction of catheters and other intravascular devices into the vasculature in adult patients.

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

• Tear Away Introducer Sheath (K153533)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

February 6, 2026

VascuTech Medical, LLC
Katy Feeny
Regulatory Affairs
98 Highland Ave.
Oaks, Pennsylvania 19456

Re: K254236
Trade/Device Name: Peel-Away Introducer Sheath
Regulation Number: 21 CFR 870.1340
Regulation Name: Catheter introducer
Regulatory Class: Class II
Product Code: DYB
Dated: December 22, 2025
Received: December 29, 2025

Dear Katy Feeny:

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K254236 - Katy Feeny
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(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 13484 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 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 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-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).

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K254236 - Katy Feeny
Page 3

Sincerely,

FINN E.
DONALDSON -
S

Digitally signed by FINN
E. DONALDSON - S
Date: 2026.02.09
14:50:49 -05'00'

For
Misti Malone
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) K254236 | |
| Device Name Peel-Away Introducer Sheath | |
| Indications for Use (Describe) The Peel-Away Introducer Sheath is intended for the percutaneous introduction of catheters and other intravascular devices into the 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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K254236
Page 1 of 4

510(k) Summary

Submitter Information

Sponsor and Application Correspondent:
Vascutech Medical, Llc
Katy Feeny
Regulatory Affairs
98 Highland Ave.
Phoenixville, PA 19460

Phone:
[phone]

Email:
[e-mail]

Date Prepared:
December 22, 2025

Device Identification:
Peel-Away Introducer Sheath

Common Name:
Catheter Introducer

Device Class:
Class II

Review Panel:
Cardiovascular

Product Code:
DYB

Regulation Number:
870.1340

Predicate Device:
Tear Away Introducer Sheath (K153533)

Device Description

Indication for Use

The Peel-Away Introducer Sheath is used for the percutaneous introduction of catheters and other intravascular devices into the vasculature.

Substantial Equivalence

The subject device Peel-Away Introducer Sheath is substantially equivalent to the predicate device Tear Away Introducer Sheath cleared under K153533. Both the subject device and the predicate device introduce catheters and other intravascular devices into the vasculature percutaneously. Evaluation of the technology characteristics demonstrates that the subject device is substantially equivalent to the predicate device. The subject device does not give rise to any new safety or performance questions.

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K254236
Page 2 of 4

| Specification | Subject Device | Predicate Device |
| --- | --- | --- |
| Device Name | Peel Away
Introducer Sheath | Tearaway Introducer Sheath |
| Manufacturer | VascuTech Medical LLC | Galt Medical Corp. |
| Specification | Subject Device | Predicate Device |
| 510k Number | TBD | K153533 |
| Product Code | DYB | DYB |
| Classification | II | II |
| Intended Use | The Peel-Away Introducer Sheath is intended for the percutaneous introduction of catheters and other intravascular devices into the vasculature. | The Tear-Away Introducer Sheath is used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads, into the vasculature. |
| Patient Population | Adults | Adults |
| Placement | Percutaneous | Percutaneous |
| Design | Outer peelable sheath and a dilator. Peelable sheath has a winged hub to facilitate the tear in the sheath | Outer peelable sheath and a dilator. Peelable sheath has a winged hub to facilitate the tear in the sheath |
| Shape | Introducer Sheath: Winged hub, cylindrical cannula. Dilator: Round hub, cylindrical cannula. | Introducer Sheath: Winged hub, cylindrical cannula. Dilator: Round hub, cylindrical cannula. |
| Introducer Sheath and Dilator Diameter | 3.5-16F | 3-16 F |
| Sheath Length | 5, 7, 10, 13 cm | 5 to 30 cm |

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K254236
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| Dilator Materials | HDPE with 20% BaSO4 | Unknown |
| --- | --- | --- |
| Sheath Materials | HDPE with 20% BaSO4 MDPE | Polytetrafluoroethylene (PTFE) |
| Specification | Subject Device | Predicate Device |
| --- | --- | --- |
| Duration of Use | Single Use Limited Duration | Single Use Limited Duration |
| Sterilization | Ethylene Oxide | Ethylene Oxide |

## Non-Clinical Testing

The subject device has been evaluated through a series of nonclinical studies to demonstrate that the device meets the acceptance criteria for its intended use.

## 1. Biocompatibility Testing

Biocompatibility testing has been performed per the requirements of ISO 10993-1:2025 as a medical device in contact with circulating blood for a limited duration. The Peel-Away Introducer Sheath complies with all biocompatibility tests:

- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemolysis
- SC5B-9 Compliment Activation

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K254236
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2. Performance Bench Testing
The following tests were performed:
- Compatibility
- Sheath Leak
- Dimensional Verification (Sheath and Dilator)
- Rigidity
- Integrity
- Visual inspection
- Break Force Test (Sheath and Dilator)
- Peel Away

As part of design verification testing, representative samples of the device underwent dimensional, tensile, and performance testing. The results demonstrate that all device performance specifications are met.

3. Sterilization
The Peel-Away Introducer Sheath is terminally sterilized using ethylene oxide to a sterility assurance level of $10^{-6}$.

Conclusion
The indications for use, sterilization, dimensions, and duration of use are the same as the predicate. Testing demonstrates that the different materials have substantially equivalent biocompatibility. It was concluded that the subject device is substantially equivalent to the predicate device.