Identifiers
- 510(k) Number
- K190644 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 Sublime Radial Access Guide Sheath is a medical device designed to facilitate radial access in patients with smaller arteries. It serves as a guiding sheath to support clinical procedures requiring vascular access.
This device is available in 5 Fr and 6 Fr sizes, including model SRA-GS35-5F150 at 150cm. It is authorized under FDA 510k clearance K190644.
Frequently asked questions
What is the primary purpose of the Sublime Radial Access Guide Sheath?
This device is designed to facilitate radial access during clinical procedures. It is specifically engineered to support vascular access in patients who have smaller arteries.
What sizes are available for this guide sheath?
The device is currently available in 5 Fr and 6 Fr sizes. This includes the specific model SRA-GS35-5F150, which features a length of 150cm.
What is the regulatory status of this device?
The Sublime Radial Access Guide Sheath is authorized under FDA 510k clearance K190644. This clearance indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.
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: Sublime™ Radial Access Guide Sheath — Sublime™ Radial Access Platform, Sublime™ Radial Access Platform, PDF Sublime Radial Access Guide Sheath Brochure SRDX-SGS-311 B, Sublime Radial Access Guide Sheath - 5Fr x 150cm
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190644 | Class II | Active |
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Manufacturer
- Manufacturer
- Surmodics, Inc.
- FDA Applicant
- Surmodics,Inc.
Sources (1)
- FDA 510(k) K190644 24 fields · synced Sep 27, 2026