Cleared Traditional

K233729 - Ringer perfusion balloon catheter, 2.00 x 20mm (5881) (FDA 510(k) Clearance)

Also includes:
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

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K233729 · Vascular Solutions, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
192d
Days
Class 2
Risk

K233729 is an FDA 510(k) clearance for the Ringer perfusion balloon catheter, 2.00 x 20mm (5881). Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Vascular Solutions, LLC (Minneapolis, US). The FDA issued a Cleared decision on May 31, 2024 after a review of 192 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vascular Solutions, LLC devices

Submission Details

510(k) Number K233729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 125d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04862689 Completed Interventional Industry-sponsored

Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)

A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA Study)

60
Patients (actual)
7
Sites
Treatment
Purpose
Open label
Masking
Condition studied Coronary Stenosis
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Sherry Lane
Sponsor Vascular Solutions LLC (industry)
Started 2022-05-01 → Primary completion 2023-06-30
Primary outcome
Effectiveness of device success in dilatation/pre-dilatation of coronary stenosis during PCI.
Secondary outcome
Successful PCI
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 85
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K233729.
Firefighter™ Pro PTCA Balloon Catheter
K252116 · Shanghai MicroPort Medical (Group) Co., Ltd. · Apr 2026
FLASH Flex™ Aorto-Ostial Angioplasty System
K254022 · Verge Medical, Inc. · Apr 2026
Ryurei
K252295 · Terumo Corporation · Mar 2026
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
K251970 · Medtronic, Ireland · Jan 2026
Pantera Pro
K242969 · Biotronik, Inc. · Oct 2024
Sapphire NC ULTRA Coronary Dilatation Catheter
K233499 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Aug 2024