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Sign in to claim this brandVELANO VASCULAR, INC.
US
Last updated May 24, 2026
What VELANO VASCULAR, INC. makes
Velano Vascular, Inc. manufactures single-use blood collection tube holders designed for peripheral intravenous (PIV) access, including models with gauge sizes 20G, 22G, and 24G, as well as a dedicated holder for total intravenous anesthesia (TIVA) applications. These devices are intended for secure attachment of blood collection tubes to PIV catheters during medical procedures.
The company’s products fall under FDA Class II regulatory classification and are listed via 510(k) clearance and the FDA’s Unique Device Identifier (UDI) system. Velano Vascular, Inc. 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 Velano Vascular, Inc. manufacture?
Velano Vascular, Inc. specializes in single-use blood collection tube holders. These devices are designed specifically for peripheral intravenous (PIV) access, ensuring secure attachment of blood collection tubes to PIV catheters during medical procedures. Examples include models like the PIVO (20G, 22G, and 24G) and the TIVA holder, which is tailored for total intravenous anesthesia applications.
Where is Velano Vascular, Inc. based, and how does that affect its regulatory standing?
Velano Vascular, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s jurisdiction ensures that products like Velano’s blood collection tube holders must comply with U.S. medical device standards, including classification, clearance, and labeling requirements.
Which regulatory registries or databases list Velano Vascular, Inc.’s devices?
Velano Vascular, Inc.’s devices are listed in the FDA’s 510(k) clearance database and the FDA’s Unique Device Identifier (UDI) system. These registries confirm that the company’s products, such as the PIVO and TIVA holders, have undergone the necessary regulatory pathways to demonstrate compliance with FDA requirements for Class II devices.
How are Velano Vascular, Inc.’s blood collection tube holders classified by the FDA?
Velano Vascular, Inc.’s blood collection tube holders fall under FDA Class II classification. This classification is determined based on the device’s intended use and associated risks. Class II devices require special controls in addition to general controls to ensure their safety and effectiveness, which aligns with the company’s focus on secure, single-use solutions for PIV access.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- velanovascular.com
- —
- —
- [email protected]
- Phone
- 844 835 2668
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 079714011
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pivo 24g | 202-0011 | FDA UDI | Class II | Active |
| Pivo 22g | 000-0011 | FDA UDI | Class II | Unknown |
| Pivo 20g | 000-0010 | FDA UDI | Class II | Unknown |
| Pivo 20g | 202-0005 | FDA UDI | Class II | Active |
| Pivo 22g | 202-0006 | FDA UDI | Class II | Active |
| Pivo | K190604 | FDA 510(k) | Class II | Active |
| Velano ExT Extension Set | K200439 | FDA 510(k) | Class II | Active |
| Velano Vascular Blood Collection Adapter | K201237 | FDA 510(k) | Class II | Active |
| Tiva¿ | K152924 | FDA 510(k) | Class II | Active |
| Pivo(tm) | K193569 | FDA 510(k) | Class II | Active |
| Pivo | K163508 | FDA 510(k) | Class II | Active |
| Velano Vascular Q2 Extension Set | K182897 | FDA 510(k) | Class II | Active |
| Tiva | K142946 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
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Importers
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Velano Vascular, Inc. has one recall record initiated on November 10, 2021, which is listed with a terminated status. The recall was due to the potential for incomplete sealing of blood collection device unit packages, which may compromise the sterile barrier and risk microbial contamination prior to use.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 10, 2021 | Z-0527-2022 | — | terminated | Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection. |