Loma Vista Medical
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Loma Vista Medical makes
Loma Vista Medical produces percutaneous transluminal valvuloplasty catheters, including a 20mm x 4.5cm TRUE Dilatation model, designed for balloon dilation of narrowed heart valves.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Loma Vista Medical, initiated on 2013-03-18. By recorded status: 1 terminated. The reasons filed fall into these groups: performance or accuracy and 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.
2013
- 18 Mar 2013 Z-1566-2013 Class II Terminated Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.
Full distribution text
- 18 Mar 2013 Z-1566-2013 Class II Terminated Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.
Frequently asked questions
How many devices does Loma Vista Medical have in the registry?
The registry currently lists 1 device for Loma Vista Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Loma Vista Medical's devices?
Among its 1 most recently registered device, Loma Vista Medical has devices listed in FDA 510(k) (1 device).
What risk classes do Loma Vista Medical's devices fall under?
Among its 1 most recently registered device, the classes recorded for Loma Vista Medical's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Loma Vista Medical?
FDA recall records list 1 recall initiated by Loma Vista Medical, the most recent initiated on 18 Mar 2013. 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 Loma Vista Medical in the registry?
The most recently registered devices listed for Loma Vista Medical include TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA.