Jostra Bentley
Country not established
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Jostra Bentley makes
Jostra Bentley manufactures extracorporeal circulation devices, including twin-pump systems like the HL-20 and modular heart-lung machines such as the HL-15. Their portfolio also includes hollow fiber membrane oxygenators, such as the Quadrox HMO 1010, designed for use in cardiopulmonary bypass procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Jostra Hl-20 Twin Pump Ref K984338
510(k) 510(k)- 510(k) 510(k)
Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 Ref K992559
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Jostra Bentley, initiated on 2002-11-01. 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.
2002
- 1 Nov 2002 Z-0312-03 Unclassified (pre-2012) Completed Separation between lid and housing unit.
Frequently asked questions
How many devices does Jostra Bentley have in the registry?
The registry currently lists 3 devices for Jostra Bentley. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jostra Bentley's devices?
Among its 3 most recently registered devices, Jostra Bentley has devices listed in FDA 510(k) (3 devices).
What risk classes do Jostra Bentley's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Jostra Bentley's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Jostra Bentley?
FDA recall records list 1 recall initiated by Jostra Bentley, the most recent initiated on 2002-11-01. 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 Jostra Bentley in the registry?
The most recently registered devices listed for Jostra Bentley include JOSTRA HL-20 TWIN PUMP, JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE and HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010.