Integrated Vascular Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Integrated Vascular Systems, Inc. makes
Integrated Vascular Systems, Inc. manufactures vascular access devices, including introducer sets and clip closure systems for securing vascular access points. These products are designed for use in procedures requiring temporary or semi-permanent vascular access, such as hemodialysis or catheter insertion.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Modification To Ivs Introducer Set, Model 1003 Ref K031583
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ivs Introducer Set, Model 1003 Ref K030723
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Integrated Vascular Systems, Inc. have in the registry?
The registry currently lists 3 devices for Integrated Vascular Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Integrated Vascular Systems, Inc.'s devices?
Among its 3 most recently registered devices, Integrated Vascular Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Integrated Vascular Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Integrated Vascular Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Integrated Vascular Systems, Inc. in the registry?
The most recently registered devices listed for Integrated Vascular Systems, Inc. include MODIFICATION TO IVS INTRODUCER SET, MODEL 1003, IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001 and IVS INTRODUCER SET, MODEL 1003.