Specialized Health Products International, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Specialized Health Products International, Inc. makes
Specialized Health Products International, Inc. manufactures infusion-related medical devices, including the SAFESTEP MAX power-injectable infusion set for intravenous administration and the LUMILOC™ safety introducer needle designed to reduce needle-stick risks during vascular access procedures.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company operates from the United States.
Catalogue
Safestep Max Power-Injectable Infusion Set Ref K073050
Regimes: 510(k) Registry: 510(k)Lumiloc (Tm) Safety Introducer Needle Ref K070449
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Specialized Health Products International, Inc. have in the registry?
The registry currently lists 2 devices for Specialized Health Products International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Specialized Health Products International, Inc.'s devices?
Among its 2 most recently registered devices, Specialized Health Products International, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Specialized Health Products International, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Specialized Health Products International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Specialized Health Products International, Inc. in the registry?
The most recently registered devices listed for Specialized Health Products International, Inc. include SAFESTEP MAX POWER-INJECTABLE INFUSION SET and LUMILOC (TM) SAFETY INTRODUCER NEEDLE.