Cleared Traditional

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

K103095 · Medtronic, Ireland · Cardiovascular
Oct 2010
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K103095 is an FDA 510(k) clearance for the SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Medtronic, Ireland (Santa Rosa, US). The FDA issued a Cleared decision on October 22, 2010, 14 days after receiving the submission on October 8, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.

Submission Details

510(k) Number K103095 FDA.gov
FDA Decision Cleared 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

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.

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