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Ostial Corporation

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K152485 FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cmLOX2016-02-16 View
510(k) K131450 FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0LOX2013-08-06 View
510(k) K122178 FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1LOX2012-10-11 View
510(k) K122379 FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CMLIT2012-09-05 View
510(k) K113775 FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MMLOX2012-06-29 View
510(k) K121175 FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CMLIT2012-06-29 View
510(k) K113582 ARCHSTENT BILIARY SYSTEMFGE2012-06-29 View
510(k) K120738 FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CMLIT2012-03-29 View
510(k) K111284 FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CMLOX2011-08-17 View
510(k) K102482 FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CMLIT2011-02-25 View
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