Teleport Glide Microcatheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253361 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Teleport Glide Microcatheter is a microcatheter designed for precise vascular access and navigation in interventional cardiology procedures. Its primary function is to facilitate the delivery of therapeutic agents, contrast media, or other interventional tools into small-diameter blood vessels, including coronary arteries and peripheral vasculature. The device is engineered with a flexible, torqueable shaft to enhance maneuverability within complex vascular anatomies, ensuring targeted intervention with reduced risk of vessel trauma.
This microcatheter is supplied as a single-use, non-sterile device, intended for use in controlled clinical settings such as catheterization laboratories. It is compatible with standard fluoroscopic imaging systems and adheres to MRI safety guidelines for external use only. Available in specified lengths and outer diameters, the device requires proper storage in a clean, dry environment to maintain integrity. Authorized under FDA 510(k) clearance, MDD, and MDR compliance, it is classified under product code DQY for regulatory filing purposes.
Frequently asked questions
What types of procedures is the Teleport Glide Microcatheter intended to assist with in the catheterization lab?
The Teleport Glide Microcatheter is designed to assist in interventional cardiology procedures where precise vascular access is required, such as delivering therapeutic agents, contrast media, or other interventional tools. Its flexible and torqueable shaft helps navigate complex blood vessels, including coronary arteries and peripheral vasculature, reducing the risk of vessel trauma during targeted interventions.
Is the Teleport Glide Microcatheter reusable, or is it meant for single-use only?
The Teleport Glide Microcatheter is explicitly supplied as a single-use device, intended for use in controlled clinical settings like catheterization labs. This design ensures patient safety and sterility, as reuse could compromise integrity and introduce infection risks.
How should the Teleport Glide Microcatheter be stored to maintain its performance?
The device must be stored in a clean, dry environment to preserve its structural integrity. Since it is non-sterile, it should not be exposed to moisture, extreme temperatures, or contamination before use in a sterile clinical setting.
Can this microcatheter be used with MRI equipment, and if so, what are the limitations?
The Teleport Glide Microcatheter adheres to MRI safety guidelines for external use only, meaning it can be used in proximity to MRI systems without interfering with imaging. However, it is not designed for internal MRI-compatible procedures, so its use must remain within fluoroscopic or other non-MRI-guided interventions.
What regulatory pathways does the Teleport Glide Microcatheter follow, and how does that affect its availability?
The device is authorized under FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) compliance. This means it has undergone regulatory review for safety and performance, ensuring it meets standards for commercial distribution in markets requiring these certifications, including the U.S. and EU.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253361 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OrbusNeich Medical (Shenzhen) Co., Ltd.
Sources (2)
- FDA 510(k) K253361 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026