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Manufacturers
US
Invatec S.P.A.
Medical Device Manufacturer
·
US , Bethlehem , PA
Invatec S.P.A. - FDA 510(k) Cleared Devices
4 submissions
·
3 cleared
·
Since 2009
4
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Invatec S.P.A.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 30, 2010
ADMIRAL XTREME PTA BALLOON DILATATION CATHETER
K100921
·
LIT
Cardiovascular
·
28d
Cleared
Oct 29, 2009
REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER
K092361
·
LIT
Cardiovascular
·
86d
Cleared
Oct 15, 2009
MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6
K092177
·
NTE
Cardiovascular
·
86d
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4
Cardiovascular
3
Gastroenterology & Urology
1