510(k) K180921

Sapphire II PRO Balloon Dilatation Catheter by Orbusneich Medical Trading, Inc. — Product Code LOX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 28, 2018
Date Received: April 9, 2018
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 Orbusneich Medical Trading, Inc.

K200269 — Sapphire II PRO (March 4, 2020)
K192344 — Sapphire NC Plus Coronary Dilatation Catheter (September 19, 2019)
K182713 — Scoreflex PTA Scoring Balloon Catheter (June 11, 2019)
K182360 — Teleport Microcatheter (November 9, 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)