Galeo Hydro and Galeo Hydro J-Tip
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K001736 FDA 510(k)
- FDA Product Code
- DQX 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 Hydro and Galeo Hydro J-Tip is a catheter guide wire designed to fit inside a percutaneous catheter for directing the catheter through a blood vessel. It is a coiled wire that facilitates navigation during cardiovascular procedures.
This device is classified as Class II with special controls and is intended for manual, non-patient contacting manipulation of non-cerebral vessels. The Galeo Hydro and Galeo Hydro J-Tip is supplied by Biotronik, Inc. and received FDA 510(k) clearance on August 2, 2000, with product code DQX.
Frequently asked questions
What is the primary purpose of the Galeo Hydro and Galeo Hydro J-Tip guide wire in cardiovascular procedures?
The Galeo Hydro and Galeo Hydro J-Tip is designed to assist in guiding a percutaneous catheter through blood vessels during cardiovascular procedures. Its coiled wire structure helps facilitate navigation, ensuring precise placement of the catheter within non-cerebral vessels.
Are the Galeo Hydro and Galeo Hydro J-Tip guide wires intended for use in cerebral vessels?
No, these guide wires are explicitly intended for manual, non-patient contacting manipulation of non-cerebral vessels only. Their design and classification reflect this limitation.
How is the Galeo Hydro and Galeo Hydro J-Tip supplied, and what regulatory pathway was followed for its clearance?
The device is supplied by Biotronik, Inc. and received FDA clearance through a 510(k) pathway (K001736) on August 2, 2000, under product code DQX. It was determined to be substantially equivalent to a predicate device and reviewed by the Cardiovascular (CV) Advisory Committee.
What type of vessel access does the Galeo Hydro and Galeo Hydro J-Tip support, and how does its design aid in navigation?
The device is intended for percutaneous catheterization of non-cerebral vessels, meaning it’s inserted through the skin to access blood vessels. Its coiled wire design provides flexibility and torque control, helping clinicians navigate tortuous vessel paths during 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: GALEO HYDRO AND GALEO HYDRO J-TIP by BIOTRONIK, INC. | FDA 510 (k) Summary, GALEO HYDRO AND GALEO HYDRO J-TIP (K001736) — FDA 510 (k) | Innolitics, GALEO HYDRO AND GALEO HYDRO J-TIP 510(k) K001736 - FDA.report, Galeo Hydro and Galeo Hydro J-tip - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001736 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K001736 24 fields · synced Sep 19, 2026