Oconnell Regulatory Consultants, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Oconnell Regulatory Consultants, Inc. makes
Oconnell Regulatory Consultants, Inc. manufactures vascular interventional devices, including the Vivo 45 LS—a catheter system—and the ELM PTA Balloon Dilatation Catheter, designed for percutaneous transluminal angioplasty procedures to treat arterial stenosis.
These devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. The company operates within the United States, adhering to U.S. medical device compliance standards.
Catalogue
Vivo 45 LS Ref K232365
Regimes: 510(k) Registry: 510(k)ELM PTA Balloon Dilatation Catheter Ref K143561
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oconnell Regulatory Consultants, Inc. have in the registry?
The registry currently lists 2 devices for Oconnell Regulatory Consultants, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oconnell Regulatory Consultants, Inc.'s devices?
Among its 2 most recently registered devices, Oconnell Regulatory Consultants, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Oconnell Regulatory Consultants, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Oconnell Regulatory Consultants, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oconnell Regulatory Consultants, Inc. in the registry?
The most recently registered devices listed for Oconnell Regulatory Consultants, Inc. include Vivo 45 LS and ELM PTA Balloon Dilatation Catheter.