Cleared Traditional

K133501 - LEADLINER CS LEAD DELIVERY SYSTEM

K133501 is an FDA 510(k) clearance for LEADLINER CS LEAD DELIVERY SYSTEM, manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K133501 · Vascular Solutions, Inc. · Cardiovascular device
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Feb 2014
Decision
103d
Days
Class 2
Risk

K133501 is an FDA 510(k) clearance for the LEADLINER CS LEAD DELIVERY SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 25, 2014 after a review of 103 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 Vascular Solutions, Inc. devices

FDA 510(k) Submission Details - K133501

510(k) Number K133501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2013
Decision Date February 25, 2014
Days to Decision 103 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
22d faster than avg
Panel avg: 125d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 666
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K133501.
ACUITY PRO LEAD DELIVERY SYSTEM
K132914 · Boston Scientific · Apr 2014
TOTAL ACROSS
K133539 · Medtronic Vascular · Mar 2014
MODIFIED HD GUIDE CATHETER
K133177 · Concentric Medical, Inc. · Feb 2014
ENLIGHTN RENAL GUIDE CATHETER
K131592 · St. Jude Medical, Inc. · Jan 2014
ADVANCE CS CORONARY SINUS INFUSION CATHETER
K131204 · Cook, Inc. · Jan 2014
UNBALLOON NON-OCCLUSION MODELING CATHETER
K133026 · LeMaitre Vascular, Inc. · Dec 2013