Gambro-Hospal, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Gambro-Hospal, Inc. makes
Gambro-Hospal, Inc. manufactures vascular access products, including the TIPSTOP™ catheter tip protector, blood-safe modification kits for subcutaneous ports (BSM/21&22), and venous pressure monitoring modifications for ports. Their portfolio also includes hemodialysis-related kits, such as the HEMOSPAL A-series (A1, A2D, AO, A1D), designed for use in medical procedures requiring sterile connections and fluid management.
These devices are classified under FDA’s Class I and Class II categories and are authorised via the 510(k) pathway. The company’s products are listed with the U.S. Food and Drug Administration, adhering to regulatory requirements for medical devices in the United States.
Catalogue
Tipstop(Tm) Ref K896068
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Hemospal Kits A1, A2D, Ao, & A1D Ref K901368
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gambro-Hospal, Inc. have in the registry?
The registry currently lists 3 devices for Gambro-Hospal, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gambro-Hospal, Inc.'s devices?
Among its 3 most recently registered devices, Gambro-Hospal, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Gambro-Hospal, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Gambro-Hospal, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gambro-Hospal, Inc. in the registry?
The most recently registered devices listed for Gambro-Hospal, Inc. include TIPSTOP(TM), BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD and HEMOSPAL KITS A1, A2D, AO, & A1D.