Solopak Medical Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Solopak Medical Products, Inc. makes
Solopak Medical Products, Inc. manufactures needle-free connectors and infusion systems, including the MAXCESS Needle-Free Connector, SOLOPAK SideKick infusion pump and administration set, SOLOPAK Paragon infusor pump and infusion set, and the MAXCESS Needlefree Y-site connector. These devices are designed for intravenous fluid administration and medication delivery in clinical settings.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.
Catalogue
Maxcess Needle Free Connector (8200) Ref K960661
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Solopak Paragon Infusor Pump And Infusion Set Ref K963355
Regimes: 510(k) Registry: 510(k)Maxcess Needlefree - Y- Site (100713) Ref K970800
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Solopak Medical Products, Inc. have in the registry?
The registry currently lists 4 devices for Solopak Medical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Solopak Medical Products, Inc.'s devices?
Among its 4 most recently registered devices, Solopak Medical Products, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Solopak Medical Products, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Solopak Medical Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Solopak Medical Products, Inc. in the registry?
The most recently registered devices listed for Solopak Medical Products, Inc. include MAXCESS NEEDLE FREE CONNECTOR (8200), SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET, SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET and MAXCESS NEEDLEFREE - Y- SITE (100713).