510(k) K233505

Sapphire ULTRA Coronary Dilatation Catheter by OrbusNeich Medical (Shenzhen) Co., Ltd. — Product Code LOX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 15, 2024
Date Received: October 31, 2023
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 (Shenzhen) Co., Ltd.

K242588 — COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) (January 7, 2025)
K233499 — Sapphire NC ULTRA Coronary Dilatation Catheter (August 16, 2024)
K241025 — JADE PLUS PTA Balloon Dilatation Catheter (June 11, 2024)
K231608 — Teleport XT Microcatheter (January 7, 2024)
K211807 — Sapphire NC 24 (October 14, 2021)
K202231 — JADE (December 10, 2020)
K201794 — Jade (July 28, 2020)

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)
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)
K220634 — NC TREK NEO Coronary Dilatation Catheter (June 30, 2022)