📋 FDA Reference
Seal-Away Hemostasis Adapter Model 406229
Diag
Summary: The Seal-Away Hemostasis Adapter is a medical device used to control bleeding during procedures involving embolization coils. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K984062 ↗
Decision Date ?
March 24, 1999
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Seal-Away Hemostasis Adapter by Diag was cleared through the FDA 510k pathway on March 24, 1999. It is a Class 2 device under product code DYB.
What It Is
The Seal-Away Hemostasis Adapter is designed to provide hemostasis during procedures that involve the insertion of embolization coils. It functions by sealing the entry site to prevent blood loss while allowing for the passage of interventional tools. This device is particularly useful in maintaining a sterile field and minimizing complications associated with vascular access.
FDA-Cleared Indications
- Use during procedures requiring the insertion of embolization coils.
- Use to provide hemostasis during coil-based vascular interventions.
Clinical Applications
- Maintaining hemostasis while embolization coils are delivered through a catheter.
- Supporting catheter-based treatment of abnormal blood vessels when embolization coils are used.
- Use during endovascular procedures performed by interventional radiology, neurointerventional, or interventional cardiology teams.
Practical Considerations
- Confirm compatibility with the catheter, delivery system, and access configuration before use.
- Select the appropriate size and ensure that the adapter forms an effective seal around the intended device.
- Use sterile technique and follow the device instructions for preparation, connection, flushing, and handling.
- Careful technique is required to reduce blood loss, air entry, thrombus formation, and loss of hemostasis.
- The available FDA record does not establish MRI safety labeling; review current manufacturer instructions before MRI exposure.
Procedures that use this device
Frequently Asked Questions
What is the Seal-Away Hemostasis Adapter used for?
It is used to control bleeding during procedures involving embolization coils.
What specialties typically use this device?
Interventional radiology and cardiology specialties typically use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring embolization coils to control bleeding or block abnormal blood vessels.
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.