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510(k) K120738

FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM by Ostial Corporation — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2012
Date Received
March 12, 2012
Clearance Type
Special
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)
  • K133861 — FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80C (July 2, 2014)
  • 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)
  • K113582 — ARCHSTENT BILIARY SYSTEM (June 29, 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)
  • K111284 — FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM (August 17, 2011)

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