Devices

Device Recall CS100 IntraAortic Balloon Pump.

Model / Serial
Product number 0998-00-3023-XX: SA122365C8 SA122373C8. International: SA122359C8 SA122375C8 SA122358C8 SA122360C8 SA122363C8 SA122362C8 SA122361C8 SA122368C8 SA147699K8 SA122366C8 SA122370C8 SA119292B8 SA122371C8 SA122364C8 SA122367C8 SA122369C8 SA122372C8.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.
Product Description
CS100 Intra-Aortic Balloon Pump.
Manufacturer
Datascope Corporation
1 Event
- Recall of Device Recall CS100 IntraAortic Balloon Pump.

Manufacturer

Datascope Corporation

Manufacturer Address
Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
Manufacturer Parent Company (2017)
Getinge AB
Source
USFDA

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