📋 FDA Reference
Novoste Pulse Plus Blood Containment Device
Novoste
Summary: The Novoste Pulse Plus Blood Containment Device is used in interventional radiology for embolization procedures. It is primarily utilized by radiologists and vascular surgeons to manage blood flow during interventions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K942977 ↗
Decision Date ?
December 28, 1995
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Novoste Pulse Plus Blood Containment Device was cleared through the FDA 510(k) pathway on December 28, 1995. Manufactured by Novoste, it is classified as a Class 2 device under product code DYB.
What It Is
The Novoste Pulse Plus Blood Containment Device is designed to manage blood flow during embolization procedures. It functions by containing and controlling blood flow to allow for precise placement of embolization coils. This device is essential in procedures where targeted embolization is required to treat vascular abnormalities or control bleeding.
FDA-Cleared Indications
- Use as a blood containment device during vascular procedures, as described under FDA product code DYB.
- The supplied FDA summary does not specify particular diseases, vessels, embolic materials, or named procedures.
Clinical Applications
- Blood containment during selected endovascular procedures.
- Temporary control or containment of blood flow when performing catheter-based vascular interventions.
- Use in interventional radiology or vascular surgery when the treating physician determines that blood containment is appropriate.
Practical Considerations
- The detailed FDA-cleared indications, device dimensions, and compatibility information should be confirmed in the official 510(k) summary and current manufacturer instructions for use.
- The supplied record does not document available sizes, working dimensions, compatible catheters, or compatibility with embolization coils; these details should not be assumed.
- Use requires fluoroscopic or other appropriate imaging guidance, sterile technique, and trained procedural staff.
- MRI safety has not been established from the supplied FDA record. Do not bring the device into an MRI environment unless its current labeling specifically identifies it as MR Safe or MR Conditional.
- Potential contraindications, warnings, and handling requirements depend on the specific model and current labeling.
Procedures that use this device
Frequently Asked Questions
What is the Novoste Pulse Plus Blood Containment Device used for?
It is used for managing blood flow during embolization procedures, particularly in treating vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for use in embolization procedures to control or redirect blood flow in conditions like aneurysms and vascular malformations.
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.