Identifiers
- 510(k) Number
- K151951 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Destino Reach Steerable Guiding Sheath is a bi-directional steerable catheter designed for vascular access. It facilitates the introduction and placement of diagnostic and therapeutic devices within the human circulatory system, including intracardiac and transseptal procedures. Its flexible shaft and hemostatic valve enable precise navigation through complex vascular pathways while maintaining hemostasis during use.
This device is supplied as a single-use, non-sterile product and requires terminal sterilization prior to use. It is intended for use in interventional cardiology and electrophysiology settings, where MRI safety is not applicable. Available in specific sizes as defined by the manufacturer, it must be stored in a clean, dry environment and handled according to sterile medical device protocols. Its regulatory status includes FDA 510(k) clearance under the Special 510(k) pathway, classified under product code DYB.
Frequently asked questions
What is the Destino Reach Steerable Guiding Sheath used for?
The Destino Reach Steerable Guiding Sheath is designed for vascular access in interventional cardiology and electrophysiology procedures. Its bi-directional steerability allows precise navigation through complex pathways, facilitating the introduction and placement of diagnostic and therapeutic devices within the circulatory system, including intracardiac and transseptal applications.
Is the Destino Reach supplied sterile?
No, the Destino Reach Steerable Guiding Sheath is supplied as a single-use, non-sterile product. Terminal sterilization must be performed prior to use, following standard sterile medical device protocols to ensure safety and efficacy.
How should the Destino Reach Steerable Guiding Sheath be stored?
The device must be stored in a clean, dry environment to maintain its integrity. Proper storage conditions help preserve its functionality and ensure it remains suitable for use when needed, adhering to sterile medical device handling guidelines.
What regulatory pathway does the Destino Reach follow?
The Destino Reach Steerable Guiding Sheath has received FDA 510(k) clearance under the Special 510(k) pathway. It is classified under product code DYB and was reviewed by the Cardiovascular Advisory Committee, demonstrating substantial equivalence to a predicate device.
Are there different sizes available for the Destino Reach?
Yes, the Destino Reach Steerable Guiding Sheath is available in specific sizes as defined by the manufacturer. These sizes are tailored to accommodate various clinical needs and procedural requirements, ensuring compatibility with different patient anatomies and device introductions.
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: Products - Oscor Fixed & Steerable Guiding Sheaths - Integer, Oscor Fixed & Steerable Guiding Sheaths - Destino™ - Integer, Destino™ Reach Steerable Sheath | Guiding Sheath | Endovascular Access
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151951 | Class II | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K151951 24 fields · synced Oct 1, 2026