Medical Device Manufacturer · US , Mountain View , CA

Ostial Corporation - FDA 510(k) Cleared Devices

12 submissions · 11 cleared · Since 2011
12
Total
11
Cleared
0
Denied

Ostial Corporation has 11 FDA 510(k) cleared cardiovascular devices. Based in Mountain View, US.

Historical record: 11 cleared submissions from 2011 to 2016.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Ostial Corporation

12 devices
1-12 of 12
Cleared Feb 16, 2016
FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System -...
K152485 · LOX
Cardiovascular · 169d
Cleared May 08, 2015
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x...
K150946 · LIT
Cardiovascular · 30d
Cleared Jul 02, 2014
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM...
K133861 · LIT
Cardiovascular · 195d
Cleared Aug 06, 2013
FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X...
K131450 · LOX
Cardiovascular · 78d
Cleared Oct 11, 2012
FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA...
K122178 · LOX
Cardiovascular · 80d
Cleared Sep 05, 2012
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON...
K122379 · LIT
Cardiovascular · 30d
Cleared Jun 29, 2012
ARCHSTENT BILIARY SYSTEM
K113582 · FGE
Gastroenterology & Urology · 207d
Cleared Jun 29, 2012
FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM...
K113775 · LOX
Cardiovascular · 190d
Cleared Jun 29, 2012
FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM
K121175 · LIT
Cardiovascular · 72d
Cleared Mar 29, 2012
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
K120738 · LIT
Cardiovascular · 17d
Cleared Aug 17, 2011
FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
K111284 · LOX
Cardiovascular · 103d
Cleared Feb 25, 2011
FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM
K102482 · LIT
Cardiovascular · 179d
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