📊 Evidence-Based Reference
Introducer Sheath Pflexi00l065 Pflexi00l070 Pflexi00l075 Pflexi00l080 Pflexi00l090 Pflexi30l065 Pflexi30l070 Pflexi30l075 Pflexi30l080 Pflexi30l090 Pflexi45l065 Pflexi45l070 Pflexi45l075 Pflexi45l080 Pflexi45l090 Pflexi60l065 Pflexi60l070 Pflexi60l075 Pflexi60l080 Pflexi60l090
Pulnovo Medical (Wuxi)
Summary: The introducer sheath by Pulnovo Medical is a device used in vascular access procedures, primarily for embolization-coils. Key evidence highlights its role in reducing radial artery complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K242756 ↗
Decision Date ?
November 8, 2024
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The introducer sheath by Pulnovo Medical received FDA clearance through the 510(k) pathway on November 8, 2024. It is classified as a Class 2 device under product code DYB.
What It Is
The introducer sheath is a medical device designed to facilitate vascular access during procedures such as embolization. It provides a conduit for the insertion of other instruments into the vasculature, minimizing trauma to the vessel.
FDA-Cleared Indications
- Provides vascular access for the introduction of diagnostic or therapeutic devices during endovascular procedures.
- Supports access to blood vessels when catheter-based treatment or imaging is required.
- Intended for use by appropriately trained healthcare professionals in a clinical setting.
Clinical Applications
- Establishing arterial or venous access before catheter-based vascular intervention.
- Providing a conduit for compatible catheters, guidewires, and embolization devices.
- Maintaining access during diagnostic angiography and endovascular treatment.
Reported off-label uses
- Use as an access sheath during embolization procedures involving pelvic, visceral, or peripheral vessels may occur in clinical practice when appropriate for the anatomy and compatible equipment.
- Use in neurointerventional procedures may be considered with suitable access planning and device compatibility, but the specific application should follow the manufacturer's labeling and institutional policy.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 10 studies, ranging from randomized controlled trials to systematic reviews, published between 2021 and 2025. These studies explore various aspects of vascular access and device efficacy.
Reported Outcomes
Published studies report that the introducer sheath effectively minimizes radial artery overstretch and spasm during procedures. It is associated with improved procedural outcomes in embolization-coil placements.
Safety Profile
Reported complications include radial artery spasm and potential occlusion, as noted in studies focusing on sheath size and vascular compatibility. Overall, the device is considered safe with proper use.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for long-term follow-up studies. Further research is needed to explore the device's efficacy in diverse patient populations.
Practical Considerations
- The product family includes 6.5F, 7.0F, 7.5F, 8.0F, and 9.0F sizes, with listed shaft lengths of 65, 70, 75, 80, or 90 cm depending on the model.
- Models include straight and angled configurations identified by 00, 30, 45, and 60 designations; the appropriate shape depends on the access route and target vessel.
- Use only with guidewires, catheters, and interventional devices that are compatible with the sheath's inner diameter, length, and connector configuration.
- The sheath is a temporary, single-use access device and is not intended for permanent implantation.
- MRI safety should be confirmed in the current manufacturer labeling. The sheath should be removed before MRI unless the specific model is expressly labeled as MR Safe or MR Conditional.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for the introducer sheath?
The introducer sheath is indicated for use in vascular access procedures, particularly in embolization-coil placements.
What outcomes have been reported in clinical studies?
Studies report effective reduction in radial artery complications and improved procedural outcomes.
What complications have been reported?
Safety data indicate potential for radial artery spasm and occlusion, though these are minimized with proper technique.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.