Echo Intracranial Base Catheter
510(k) K241637
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241637 | Date19 Dec 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QJP
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Echo Intracranial Base Catheter is a catheter, percutaneous, neurovascular (per OpenFDA nomenclature), designed for neurovascular interventions. It features a single lumen with an inner diameter of 0.100 inch, providing a flexible yet variable-stiffness pathway for guiding interventional devices within the intracranial vasculature. The device incorporates a radiopaque marker band at the distal end to enhance fluoroscopic visualization and a Luer hub at the proximal end for secure connection to delivery systems.
This catheter is intended for single-use in sterile neurovascular procedures, supplied as a reusable or disposable component depending on institutional protocols. It is classified as a Class II medical device under FDA regulations (870.1250) and has received FDA 510(k) clearance (K241637) as substantially equivalent to a predicate device. Compatibility with MRI environments is not specified, and storage requirements align with standard sterile catheter handling protocols.
From the manufacturer
The Echo Intracranial Base Catheter is a single lumen, flexible, variable stiffness catheter with an 0.100 inch inner diameter, designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the neurovascular system. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end.
Echo Intracranial Base Catheter Engineered with our newest 36OMax laser technology, Echo provides a supportive base with a large 0.100in lumen for optimal delivery of Broadway 8.
Other devices from Stryker Neurovascular
Questions
AI-generated answers, 19 Sep 2026
What is the Echo Intracranial Base Catheter primarily used for in clinical practice?
The Echo Intracranial Base Catheter is designed for neurovascular interventions, specifically as a percutaneous catheter to guide interventional devices within the intracranial vasculature. Its flexible yet variable-stiffness lumen allows for precise navigation during procedures like embolizations or stent placements in blood vessels of the brain.
Is the Echo Intracranial Base Catheter intended for reuse, or is it meant to be used only once?
The Echo Intracranial Base Catheter is explicitly labeled for single-use in sterile neurovascular procedures. However, whether it is supplied as a reusable or disposable component depends on institutional protocols, so check your facility’s guidelines for proper handling.
How do I identify the correct size or model of the Echo Intracranial Base Catheter for my procedure?
The device features a single lumen with an inner diameter of 0.100 inch, which is the primary sizing specification. While multiple registration numbers are listed, these correspond to administrative tracking rather than distinct clinical models. Confirm compatibility with your specific interventional tools, as the lumen size determines what devices can be guided through it.
How should the Echo Intracranial Base Catheter be stored before use, and what sterility precautions should be taken?
The catheter must be stored according to standard sterile catheter protocols, as it is intended for sterile procedures. Ensure it remains in its original packaging until immediately before use, and follow manufacturer instructions for unpacking to maintain sterility. Since it is single-use, avoid reprocessing or reuse to prevent contamination.
Does the Echo Intracranial Base Catheter have any features to aid visualization during fluoroscopy?
Yes, the Echo Intracranial Base Catheter includes a radiopaque marker band at the distal end, which enhances visibility under fluoroscopy. This helps clinicians accurately position the catheter within the intracranial vasculature during procedures.