Inneuroco, Inc.
United StatesFDA applicant, unverified
- Devices
- 21
What Inneuroco, Inc. makes
Inneuroco, Inc. manufactures neurovascular access and support devices, including sheaths (e.g., 091 Long Sheath in 70 cm, 80 cm, and 90 cm lengths), balloon guide catheters (e.g., 091 Balloon Guide Catheter), and introducer systems (e.g., Thinline Sheath Introducer). Their portfolio also includes flexible neurovascular systems like the Zenith Flex (046 and 074) and the Zenith Flex System, designed for distal access procedures. Additional products like the Super Distal Access (SDA) and support catheters (e.g., Zenith Support in 95 cm, 105 cm, and 115 cm lengths) are intended for neurointerventional applications.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry. Inneuroco, Inc. is based in the United States.
Catalogue
Search and filter all 21 devicesCompany details
- DUNS number
- 080407341
- [email protected]
- Phone
- (954) 742-5988
Frequently asked questions
How many devices does Inneuroco, Inc. have in the registry?
The registry currently lists 21 devices for Inneuroco, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Inneuroco, Inc.'s devices?
Among its 21 most recently registered devices, Inneuroco, Inc. has devices listed in FDA 510(k) (9 devices) and FDA GUDID (12 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Inneuroco, Inc.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Inneuroco, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Inneuroco, Inc. in the registry?
The most recently registered devices listed for Inneuroco, Inc. include Intermediate Catheter GEN-10815-115, Intermediate Catheter GEN-10815-125, Intermediate Catheter GEN-10815-105 and SYPHONTRAK GEN-10815-115.