FDA-Device2014-05-21Class II
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
InterValve Inc
Hazard
Leak issues were discovered through accelerated age testing.
Sold states
Distribution to TN only
Affected count
2
Manufactured in
16200 State Highway 7, Unit B, Minnetonka, MN, United States
Products
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1621-2014Don't want to check this manually?
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