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Sign in to claim this brandRhythm Xience, Inc. (Rxi)
US
Last updated May 23, 2026
What Rhythm Xience, Inc. (Rxi) makes
Rhythm Xience, Inc. manufactures vascular access devices, including the Guider Catheter Introducer and the Flextra Steerable Introducer, designed for guiding and positioning catheters within blood vessels during interventional procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Rhythm Xience, Inc. manufacture?
Rhythm Xience, Inc. specializes in vascular access devices, specifically the Guider Catheter Introducer and the Flextra Steerable Introducer. These devices are engineered to assist in guiding and positioning catheters within blood vessels during interventional procedures, ensuring precise access for treatments like angiography or angioplasty.
Where is Rhythm Xience, Inc. based?
The company, Rhythm Xience, Inc., is headquartered in the United States. This location allows them to operate within the regulatory framework of the FDA, which governs the classification and authorization of their medical devices.
Which regulatory registries or databases list Rhythm Xience, Inc.’s devices?
Rhythm Xience, Inc.’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class II devices, which require pre-market submission to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution.
How are Rhythm Xience, Inc.’s devices classified under FDA regulations?
The devices manufactured by Rhythm Xience, Inc., such as the Guider Catheter Introducer and Flextra Steerable Introducer, fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Flextra Steerable Introducer | 122852 | FDA UDI | Class II | Active |
| Guider Catheter Introducer | 112851 | FDA UDI | Class II | Active |
| Flextra Steerable Introducer | 122851 | FDA UDI | Class II | Active |
| Guider Catheter Introducer | 111851 | FDA UDI | Class II | Active |
| Guider Catheter Introducer | 112852 | FDA UDI | Class II | Active |
| Guider Catheter Introducer | 111852 | FDA UDI | Class II | Active |
| Guider Catheter Introducer | K171081 | FDA 510(k) | Class II | Active |
| Flextra Steerable Introducer | K170373 | FDA 510(k) | Class II | Active |
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