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510(k) K122178

FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 by Ostial Corporation — Product Code LOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2012
Date Received
July 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class
Class II
Regulation Number
870.5100
Review Panel
CV
Submission Type

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

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)
  • 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)
  • 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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  • K242969 — Pantera Pro; Pantera LEO (October 25, 2024)
  • K233499 — Sapphire NC ULTRA Coronary Dilatation Catheter (August 16, 2024)
  • K233505 — Sapphire ULTRA Coronary Dilatation Catheter (August 15, 2024)
  • K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon (May 31, 2024)
  • K223189 — Firefighter™ NC Pro PTCA Balloon Catheter (July 21, 2023)
  • K230374 — Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Ballo (June 29, 2023)
  • K230705 — POT PTCA Balloon Dilatation Catheter (April 11, 2023)
  • K223022 — SC HONKYTONK PTCA Balloon Dilatation Catheter (February 15, 2023)
  • K222538 — NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter (December 21, 2022)