đź“‹ FDA Reference
Modified Softouch Introducer W Hemo Valve Side
Mallinckroot
Summary: The Modified Softouch Introducer with Hemo Valve Side is a medical device used primarily in interventional radiology for procedures involving embolization coils. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K894445 ↗
Decision Date ?
October 2, 1989
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Modified Softouch Introducer with Hemo Valve Side was cleared through the FDA 510(k) pathway on October 2, 1989. Manufactured by Mallinckroot, it is classified as a Class 2 device under product code DYB.
What It Is
The Modified Softouch Introducer with Hemo Valve Side is a specialized catheter introducer designed to facilitate the insertion of embolization coils into the vascular system. It features a hemostatic valve to minimize blood loss during procedures. The device is engineered to provide smooth and controlled access to the vascular system, enhancing procedural efficiency and safety.
FDA-Cleared Indications
- Use as an introducer for the placement of embolization coils during vascular procedures.
Clinical Applications
- Providing vascular access for embolization-coil procedures.
- Supporting catheter-based treatment of vascular lesions when embolization coils are indicated.
- Maintaining hemostasis around an inserted catheter or embolization system during the procedure.
Practical Considerations
- Confirm the introducer size and compatibility with the selected catheter, guidewire, and embolization-coil delivery system before use.
- The hemostatic valve should be handled according to the manufacturer’s instructions to reduce blood loss and air entry.
- The available record does not establish that this device is MRI safe or MRI conditional; confirm its labeling before an MRI examination.
- As with other vascular introducers, potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and contrast-related reactions.
- Do not use when the access vessel is unsuitable or when the patient has a contraindication to the planned vascular procedure; the treating clinician should review the current instructions for use.
Procedures that use this device
Frequently Asked Questions
What is the Modified Softouch Introducer with Hemo Valve Side used for?
It is used to facilitate the insertion of embolization coils into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the placement of embolization coils, such as treating vascular anomalies or controlling bleeding.
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.