Cleared Traditional

Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58

K233729 · Vascular Solutions, LLC · Cardiovascular

May 2024

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K233729 is an FDA 510(k) clearance for the Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Vascular Solutions, LLC (Maple Grove, US). The FDA issued a Cleared decision on May 31, 2024, 192 days after receiving the submission on November 21, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.

Submission Details

510(k) Number	K233729 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2023
Decision Date	May 31, 2024
Days to Decision	192 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.