510(k) K252295

Ryurei by Terumo Corporation — Product Code LOX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 27, 2026
Date Received: July 23, 2025
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 Terumo Corporation

K250700 — Pen Injector Needle 32.5 (November 21, 2025)
K250751 — DualView Catheter (July 17, 2025)
K240818 — R2P Radifocus Glidewire Advantage (November 26, 2024)
K240859 — Glidewire GT-R (August 21, 2024)
K190427 — Immucise (July 18, 2019)
K181369 — Immucise Intradermal Injection System (November 13, 2018)
K173799 — NaviCross 0.018 (March 29, 2018)
K170417 — Glidewire GT (September 15, 2017)
K130280 — CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR (March 13, 2013)
K130493 — CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR (March 13, 2013)

Other clearances for product code LOX

K252116 — Firefighter Pro PTCA Balloon Catheter (April 7, 2026)
K254022 — FLASH Flex Aorto-Ostial Angioplasty System (April 2, 2026)
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)