Intervalve, Inc.
United StatesFDA applicant, unverified
- Devices
- 17
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Intervalve, Inc. makes
Intervalve, Inc. manufactures transluminal balloon aortic valvuloplasty catheters, including the V8 Balloon Aortic Valvuloplasty Catheter, designed for percutaneous dilation of stenotic aortic valves.
These devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Search and filter all 17 devicesCompany details
- DUNS number
- 037375827
- [email protected]
- Phone
- 6123969849
FDA recalls
FDA recall records list 1 recall initiated by Intervalve, Inc., initiated on 2014-03-14. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 14 Mar 2014 Z-1621-2014 Class II Terminated Leak issues were discovered through accelerated age testing.
Frequently asked questions
How many devices does Intervalve, Inc. have in the registry?
The registry currently lists 17 devices for Intervalve, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intervalve, Inc.'s devices?
Among its 17 most recently registered devices, Intervalve, Inc. has devices listed in FDA 510(k) (5 devices) and FDA GUDID (12 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Intervalve, Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Intervalve, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Intervalve, Inc.?
FDA recall records list 1 recall initiated by Intervalve, Inc., the most recent initiated on 14 Mar 2014. 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 Intervalve, Inc. in the registry?
The most recently registered devices listed for Intervalve, Inc. include V8 V8-2328, V8 TAV8-1924, V8 V8-1924 and V8 TAV8-2126.