Shiley Infusaid, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Shiley Infusaid, Inc. makes
Shiley Infusaid, Inc. manufactures polyurethane catheters designed for use with the Infuse-A-Port system, including additional sizes and radiopaque variants. These catheters are intended for venous access in medical procedures requiring repeated injections or infusions.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Polyurethane Catheter For The Infuse-A-Port Ref K872898
Regimes: 510(k) Registry: 510(k)Infuse-A-Port Additional Sizes Ref K872329
Regimes: 510(k) Registry: 510(k)Infuse-A-Port Radiopaque Polyurethane Catheter Ref K881745
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Shiley Infusaid, Inc. have in the registry?
The registry currently lists 3 devices for Shiley Infusaid, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shiley Infusaid, Inc.'s devices?
Among its 3 most recently registered devices, Shiley Infusaid, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Shiley Infusaid, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Shiley Infusaid, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shiley Infusaid, Inc. in the registry?
The most recently registered devices listed for Shiley Infusaid, Inc. include POLYURETHANE CATHETER FOR THE INFUSE-A-PORT, INFUSE-A-PORT ADDITIONAL SIZES and INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER.