📋 FDA Reference
Usci R Hemaflex Tm Introducer with Coating
Summary: The USCI R HemaFlex Introducer with coating is a medical device used primarily in interventional radiology and cardiology for vascular access. It is designed for clinicians performing procedures that require the introduction of embolization coils.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K915553 ↗
Decision Date ?
February 21, 1992
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The USCI R HemaFlex Introducer was cleared through the FDA 510(k) pathway on February 21, 1992. Manufactured by C.R. Bard, it is classified as a Class II device under product code DYB.
What It Is
The USCI R HemaFlex Introducer is a vascular access device that facilitates the insertion of embolization coils and other interventional tools into the vascular system. It features a specialized coating to reduce friction and improve ease of insertion. This device is typically used in procedures that require precise and reliable vascular access, such as embolization therapies.
FDA-Cleared Indications
- Intended for use as an introducer for the insertion of embolization coils into the vascular system.
- Used by trained clinicians during endovascular procedures that require vascular access for embolization devices.
Clinical Applications
- Providing vascular access for embolization-coil procedures.
- Supporting catheter and coil delivery during endovascular treatment of selected aneurysms.
- Supporting delivery of embolization devices during treatment of selected arteriovenous malformations.
- Providing access during other procedures in which embolization coils are inserted into a blood vessel, when consistent with the device labeling.
Reported off-label uses
- Use as an access sheath for selected non-coil catheters or embolic materials may occur in clinical practice, but this should not be assumed to be covered by the device labeling.
- Use in procedures such as uterine, prostate, ovarian-vein, varicocele, portal-vein, visceral, splenic, or gastrointestinal embolization may be off-label depending on the specific device size, configuration, and labeling.
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.
Practical Considerations
- The device is available in different sizes; clinicians should select the introducer size and length based on the access vessel, catheter or coil system, and procedure.
- The coating is intended to reduce friction during insertion, but standard wire and catheter manipulation techniques remain necessary.
- Compatibility with a particular embolization coil, catheter, guidewire, or other device should be confirmed in the current manufacturer instructions for use.
- MRI safety and conditional-use information should be verified from the current product labeling; this record alone does not establish that the device is MR safe or MR conditional.
- Potential access-related complications include bleeding, hematoma, infection, thrombosis, vessel injury, embolization, and contrast-related complications. Contraindications and warnings should be reviewed in the current labeling.
Procedures that use this device
Frequently Asked Questions
What is USCI R HemaFlex Introducer used for?
It is used for vascular access in procedures requiring the insertion of embolization coils, such as in the treatment of aneurysms.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital and specialized clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the introduction of embolization coils, typically for vascular interventions.
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.