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24-Gauga "TIVA" Device Initiative

Project Lead: VelanoVascular
Year: 

2014

Anticipated Classification:

Class II

Anticipated Regulatory Path:

510(k)

Initial Development Stage:

Prototyping

Current Development Stage:

Prototyping

Velano Vascular aims to reduce unnecessary needle sticks and high-risk line draws via a patented device technology that offers a painless and reliable alternative to both venipuncture and CVC/PICC line draws. Velano’s family of devices seek to repurpose the peripheral IV catheter (PIVC) that is placed in both neonates (24 gauge) and pre-adolescents and teens (22 gauge) for simple, safe blood drawing purposes. Velano’s blood draw system overcomes mechanical barriers to PIV aspiration. NCC-PDI has provided pediatric market research, regulatory planning, R&D engineering and manufacturing, and pediatric clinical study planning.

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The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) serves as a critical device development resource by providing expert advice, support services, and fund management of pediatric device innovation.

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