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510(k) K192344

Sapphire NC Plus Coronary Dilatation Catheter by Orbusneich Medical Trading, Inc. — Product Code LOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2019
Date Received
August 29, 2019
Clearance Type
Special
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 Orbusneich Medical Trading, Inc.

  • K200269 — Sapphire II PRO (March 4, 2020)
  • K182713 — Scoreflex PTA Scoring Balloon Catheter (June 11, 2019)
  • K182360 — Teleport Microcatheter (November 9, 2018)
  • K180921 — Sapphire II PRO Balloon Dilatation Catheter (June 28, 2018)
  • K173680 — Sapphire II PRO (March 1, 2018)
  • K173894 — Jade PTA Balloon Dilatation Catheter (February 9, 2018)

Other clearances for product code LOX

  • K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (January 17, 2026)
  • 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)