510(k) K123473

HOPER PTCA BALLOON CATHETER by Lepu Medical Technology (Beijing) Co., Ltd. — Product Code LOX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 13, 2013
Date Received: November 13, 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 Lepu Medical Technology (Beijing) Co., Ltd.

K172331 — Type I, Type II, Type III, Type IV (March 2, 2018)
K172099 — Shoocin Introducer Kit (October 5, 2017)
K141707 — ULTRASKIN HYDROPHILIC GUIDE WIRE (January 21, 2015)
K142359 — Vasc Band hemostat (October 23, 2014)
K123475 — SHOOCIN INTRODUCER KIT (February 3, 2014)
K111837 — RADIAL ARTERY COMPRESSION TOURNIQUET (September 27, 2011)

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)