Cleared Traditional

K103095 - SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON

K103095 is an FDA 510(k) clearance for SPRINTER LEGEND 1.25MM RX AND SPRINTER ..., manufactured by Medtronic, Ireland. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K103095 · Medtronic, Ireland · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
14d
Days
Class 2
Risk

K103095 is an FDA 510(k) clearance for the SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Medtronic, Ireland (Santa Rosa, US). The FDA issued a Cleared decision on October 22, 2010 after a review of 14 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic, Ireland devices

FDA 510(k) Submission Details - K103095

510(k) Number K103095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2010
Decision Date October 22, 2010
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

LOX Device Classification - Class 2, Special Controls

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
NCT00961311 Completed Interventional Industry-sponsored

Sprinter Legend Balloon Catheter

Evaluation of Acute Safety and Efficacy of the Medtronic Sprinter Legend 1.25mm Balloon Dilation Catheter Utilized for Enlarging Coronary Luminal Diameters During PCI Procedures

51
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Coronary Artery Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator David Kandzari, MD
Sponsor Medtronic Vascular (industry)
Started 2009-08-01 → Primary completion 2010-01-01
Primary outcome
Procedural Success
Secondary outcome
Major Adverse Cardic Events (MACE)
View full study on ClinicalTrials.gov

Regulatory Peers - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 86
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K103095.
NC TREK RX CORONARY DILATATION CATHETER
K110134 · Abbott Vascular-Cardiac Therapies · Feb 2011
MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
K103110 · Abbott Vascular-Cardiac Therapies · Jan 2011
VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER
K103153 · Abbott Vascular-Cardiac Therapies · Dec 2010
THE PILOT SCIMED TORQUE DEVICE
K896108 · Scimed Life Systems, Inc. · Jan 1990
ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
K861847 · Advanced Cardiovascular Systems, Inc. · Jun 1986
PTCA BALLOON CATHETERS & ACCESSORIES
K843944 · Advanced Cardiovascular Systems, Inc. · Feb 1985