Cardio-Vascular Innovations, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Cardio-Vascular Innovations, Inc. makes
Cardio-Vascular Innovations, Inc. manufactures central venous catheter systems and introducer sheaths for percutaneous procedures. Their portfolio includes dual-lumen central vein catheters, tri-access compact catheters, and 16-gauge central vein catheterization systems, designed for venous access in medical settings. These devices are intended for use in procedures requiring multiple lumen access or secure catheter placement.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for commercial distribution within the United States. No additional regulatory listings outside the FDA are referenced.
Catalogue
Oz Power Syringe Ref K973334
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
French 7 Tri-Access Compact Central Vein Ref K843500
Regimes: 510(k) Registry: 510(k)7 French Dual Lumen Com Cent Vein Cath Sys Ref K852791
Regimes: 510(k) Registry: 510(k)Cvi 16 Gauge Central Vein Catherization System Ref K863916
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardio-Vascular Innovations, Inc. have in the registry?
The registry currently lists 5 devices for Cardio-Vascular Innovations, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardio-Vascular Innovations, Inc.'s devices?
Among its 5 most recently registered devices, Cardio-Vascular Innovations, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Cardio-Vascular Innovations, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Cardio-Vascular Innovations, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardio-Vascular Innovations, Inc. in the registry?
The most recently registered devices listed for Cardio-Vascular Innovations, Inc. include OZ POWER SYRINGE, CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS., FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN and 7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS.