Galeo Hs 014 (117 130 +3 more)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K982272 FDA 510(k)
- FDA Product Code
- DQX FDA 510(k)
- Models / Variants
- 117 130 FDA 510(k)Galeo S 014 Model 115 488 FDA 510(k)Galeao M 014 Model 114156 FDA 510(k)Galeo F 014 Model 115 487 Galeo Hf 018 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Galeo Guide Wire Family consists of coronary vascular guide wires designed with various levels of flexibility. These devices feature a nominal diameter of 0.014 inches and a nominal length of 175 cm, available in straight configurations including Highly Stiff, Stiff, Medium, Flexible, and Highly Flexible options.
This device family includes nine coronary guide wires and one extension wire, identified by model numbers such as 117 130, 115 488, 114156, and 115 487. The Galeo series has received FDA 510(k) clearance. Specific storage, sterility, and usage instructions are provided by the manufacturer, Biotronik, Inc.
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: GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115… - FDA.report, GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 ..., K982272 FDA 510(k) - GALEO HS 014 MODEL 117 130, GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982272 | Class II | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K982272 24 fields · synced Oct 6, 2026