Atlas FDA

MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM

FDA 510(k) clearance K033134 · decided 2003-11-17

Clearance details

K-number
K033134
Device name
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
Applicant
Ev3, Inc.
Decision
Unknown
Date received
2003-09-30
Decision date
2003-11-17
Days to decision
48 days
Clearance type
Special
Product code
FGE
Device class
2
Regulation number
876.5010
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Plymouth, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm recall (Z-0597-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm recall (Z-0598-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm recall (Z-0599-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm recall (Z-0600-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm recall (Z-0601-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm recall (Z-0602-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm recall (Z-0603-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm recall (Z-0604-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm recall (Z-0605-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm recall (Z-0606-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm recall (Z-0607-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm recall (Z-0608-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm recall (Z-0609-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm recall (Z-0610-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm recall (Z-0611-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm recall (Z-0612-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm recall (Z-0613-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm recall (Z-0614-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0615-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0616-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0617-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0618-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0619-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0620-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0621-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0622-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0623-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0624-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0625-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0626-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0627-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0628-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0629-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0630-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0631-04)ev3, Inc.2004-07-20
ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery recall (Z-0632-04)ev3, Inc.2004-07-20