Innerdyne, Inc.
United StatesFDA applicant, unverified
- Devices
- 12
What Innerdyne, Inc. makes
Innerdyne, Inc. manufactures expandable vascular access ports and radially expanding dilation devices for minimally invasive procedures. Their portfolio includes trocar-based expandable ports (e.g., STEP, ONESTEP, MINISTEP, OPEN STEP) designed for percutaneous access, as well as vascular dilation tools (e.g., RED Device, G-RED Device) for catheter placement. The company also produces heparin-coated vascular access systems and a percutaneous gastrostomy kit under the Kangaroo and Entristar brands.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Products are listed in the FDA’s 510(k) database. Innerdyne, Inc. is based in the United States.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Innerdyne, Inc. have in the registry?
The registry currently lists 12 devices for Innerdyne, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Innerdyne, Inc.'s devices?
Among its 12 most recently registered devices, Innerdyne, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Innerdyne, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Innerdyne, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Innerdyne, Inc. in the registry?
The most recently registered devices listed for Innerdyne, Inc. include INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP:, INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS), INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP and INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE.