Cleared Traditional

K133026 - UNBALLOON NON-OCCLUSION MODELING CATHETER

K133026 is the FDA 510(k) clearance for UNBALLOON NON-OCCLUSION MODELING CATHETER by LeMaitre Vascular, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K133026 · LeMaitre Vascular, Inc. · Cardiovascular device
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Dec 2013
Decision
96d
Days
Class 2
Risk

K133026 is an FDA 510(k) clearance for the UNBALLOON NON-OCCLUSION MODELING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on December 31, 2013 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 LeMaitre Vascular, Inc. devices

Submission Details

510(k) Number K133026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2013
Decision Date December 31, 2013
Days to Decision 96 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 582
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K133026.
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K133177 · Concentric Medical, Inc. · Feb 2014
LEADLINER CS LEAD DELIVERY SYSTEM
K133501 · Vascular Solutions, Inc. · Feb 2014
ADVANCE CS CORONARY SINUS INFUSION CATHETER
K131204 · Cook, Inc. · Jan 2014
SOFIA DISTAL ACCESS CATHETER
K131482 · MicroVention, Inc. · Nov 2013
TRANSGATE GUIDE CATHETER
K132542 · Stryker Neurovascular · Nov 2013
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
K132556 · Asahi Intecc Co., Ltd. · Oct 2013