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510(k) K133861

FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM by Ostial Corporation — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2014
Date Received
December 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Ostial Corporation

  • K152485 — FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm (February 16, 2016)
  • K150946 — FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12m (May 8, 2015)
  • K131450 — FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM (August 6, 2013)
  • K122178 — FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALL (October 11, 2012)
  • K122379 — FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DI (September 5, 2012)
  • K113775 — FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 1 (June 29, 2012)
  • K121175 — FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM (June 29, 2012)
  • K113582 — ARCHSTENT BILIARY SYSTEM (June 29, 2012)
  • K120738 — FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM (March 29, 2012)
  • K111284 — FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM (August 17, 2011)

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