EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay A…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180169 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 EagleRay Long Sheath and Access Catheters are percutaneous catheters designed for vascular access procedures. These devices feature varying inner diameters (ID) and lengths to accommodate different patient anatomies and procedural requirements, facilitating safe and precise catheter insertion into blood vessels.
These catheters are intended for single-use in clinical settings and are supplied sterile. They are classified under 21 CFR 870.1250 as Class II devices, with FDA 510(k) clearance (K180169) for use in percutaneous vascular access. The EagleRay Long Sheath and Access Catheters are available in multiple sizes to ensure compatibility with various interventional procedures.
Frequently asked questions
What are the primary use cases for the EagleRay Long Sheath and Access Catheters in clinical settings?
The EagleRay Long Sheath and Access Catheters are designed for percutaneous vascular access procedures, meaning they are inserted through the skin to access blood vessels. Their varying inner diameters (ranging from 0.035 to 0.088 inches) and lengths (from 80 cm to 158 cm) allow for compatibility with different patient anatomies and procedural needs, such as guiding wires or other interventional tools during cardiovascular interventions.
Are the EagleRay Long Sheath and Access Catheters reusable, or are they intended for single-use only?
The EagleRay Long Sheath and Access Catheters are explicitly stated as intended for single-use in clinical settings. This design ensures patient safety and sterility, as reuse could introduce contamination or compromise device integrity.
How are these catheters supplied, and what should I consider regarding sterility?
The EagleRay Long Sheath and Access Catheters are supplied sterile by the manufacturer. Since they are single-use devices, they are packaged in a way that maintains sterility until first use, eliminating the need for additional sterilization procedures in the clinical setting.
What are the available sizes and lengths for the EagleRay Access Catheters, and how do they differ?
The EagleRay Access Catheters come in four inner diameter (ID) sizes: 0.071” (137 cm), 0.055” (137 cm), 0.045” (144 cm), and 0.035” (158 cm). The varying lengths and diameters accommodate different procedural requirements, such as compatibility with smaller or larger guidewires or patient-specific vascular access needs.
What regulatory pathway was followed for FDA clearance of these catheters, and what does that mean for clinicians?
The EagleRay Long Sheath and Access Catheters received FDA 510(k) clearance (K180169) under the traditional review pathway, with a decision described as *Substantially Equivalent* to a predicate device. This means the FDA determined they meet the same performance standards as an existing approved device, ensuring they comply with safety and effectiveness requirements for percutaneous vascular access procedures.
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. Sources consulted: EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths ..., K180169 - EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 10..., EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180169 | Class II | Active |
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Manufacturer
- Manufacturer
- Imperative Care, Inc.
Sources (1)
- FDA 510(k) K180169 24 fields · synced Oct 6, 2026