Vascular Insights, LLC
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Vascular Insights, LLC makes
Vascular Insights, LLC manufactures venous access catheters, including the CLARIVEIN CATHETER and ClariVein IC, designed for peripheral and central venous catheterization procedures.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Clarivein Catheter Ref K071468
Regimes: 510(k) Registry: 510(k)ClariVein IC Ref K153502
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 969986236
- [email protected]
- Phone
- 203-446-5711
FDA recalls
FDA recall records list 1 recall initiated by Vascular Insights, LLC, initiated on 2017-11-09. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 9 Nov 2017 Z-1146-2018 Class II Terminated Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.
Frequently asked questions
How many devices does Vascular Insights, LLC have in the registry?
The registry currently lists 6 devices for Vascular Insights, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vascular Insights, LLC's devices?
Among its 6 most recently registered devices, Vascular Insights, LLC has devices listed in FDA 510(k) (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Vascular Insights, LLC's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Vascular Insights, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vascular Insights, LLC?
FDA recall records list 1 recall initiated by Vascular Insights, LLC, the most recent initiated on 9 Nov 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Vascular Insights, LLC in the registry?
The most recently registered devices listed for Vascular Insights, LLC include ClariVein® IC 45-018-E2S, ClariVein® IC DEMO-45-018-E2S, ClariVein® IC 85-018-E140S and ClariVein® IC 65-018-E4S.