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Sign in to claim this brandInnovations IN Access, Inc.
US
Last updated May 23, 2026
What Innovations IN Access, Inc. makes
Innovations IN Access, Inc. manufactures the HEMO-BAND, a medical device designed for vascular access applications, including the secure attachment of catheters to blood vessels.
The HEMO-BAND is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. 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 Innovations IN Access, Inc. manufacture?
Innovations IN Access, Inc. specializes in vascular access devices. Their primary product, the HEMO-BAND, is designed to securely attach catheters to blood vessels, ensuring stable and reliable vascular access for medical procedures.
Where is Innovations IN Access, Inc. based?
The company is headquartered in the United States. This location allows them to operate within the regulatory framework of the FDA, which governs medical device authorization in the country.
How are the devices made by Innovations IN Access, Inc. classified under FDA regulations?
The HEMO-BAND, the company’s key device, is classified as a Class II medical device by the FDA. This classification is based on its intended use—vascular access—and the associated risk level, which requires special controls to ensure safety and effectiveness beyond general controls.
Which regulatory registries list devices from Innovations IN Access, Inc.?
The HEMO-BAND is included in the FDA’s 510(k) clearance registry. This registry documents devices that have been determined to be substantially equivalent to a legally marketed predicate device, allowing them to enter the market through the 510(k) pathway.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HemoBand | HB-1M | FDA UDI | Class II | Active |
| HemoBand | HB-NSXL | FDA UDI | Class II | Active |
| HemoBand | HB-NS | FDA UDI | Class II | Active |
| Hemoband, Models Hb-Ns And Hb-Nsxl | K081740 | FDA 510(k) | Class II | Active |
| Hemo-Band | K920614 | FDA 510(k) | Class II | Active |
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