Cleared Traditional

Firefighter? NC Pro PTCA Balloon Catheter

K223189 · Shanghai MicroPort Medical (Group) Co., Ltd. · Cardiovascular

Jul 2023

Decision

282d

Days

Class 2

Risk

About This 510(k) Submission

K223189 is an FDA 510(k) clearance for the Firefighter? NC Pro PTCA Balloon Catheter, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Shanghai MicroPort Medical (Group) Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 21, 2023, 282 days after receiving the submission on October 12, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.

Submission Details

510(k) Number	K223189 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 12, 2022
Decision Date	July 21, 2023
Days to Decision	282 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5100
Definition	A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.