Cleared Traditional

K121415 - MOLLRING MULTITASC

K121415 is an FDA 510(k) clearance for MOLLRING MULTITASC, manufactured by LeMaitre Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code DWX cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K121415 · LeMaitre Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
117d
Days
Class 2
Risk

K121415 is an FDA 510(k) clearance for the MOLLRING MULTITASC. Classified as Stripper, Artery, Intraluminal (product code DWX), Class II - Special Controls.

Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on September 5, 2012 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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.

FDA 510(k) Submission Details - K121415

510(k) Number K121415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2012
Decision Date September 05, 2012
Days to Decision 117 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
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWX Device Classification - Class 2, Special Controls

Product Code DWX Stripper, Artery, Intraluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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 - DWX Stripper, Artery, Intraluminal

All 13
Devices cleared under the same product code (DWX) and FDA review panel - the closest regulatory comparables to K121415.
ENDOHELIX ENDARTERECTOMY DEVICE
K032105 · Endarx, Inc. · Oct 2003
CARBODISSECTING ENDOSCOPE
K020925 · Endo Surgical Devices, Inc. · Apr 2003
VASCULAR ARCHITECTS PERISCOPE DEVICE
K003719 · Vascular Architects, Inc. · Feb 2001
MOLLRING CUTTER
K950813 · Cardio Vascular Concepts, Inc. · Jul 1995
EXTERNAL VEIN STRIPPER
K933498 · Applied Medical Resources · Mar 1994
INTRALUMINAL ARTERY STRIPPER
K913803 · Omni-Tract Surgical, Div. Minn. Scientific, Inc. · Apr 1992
K121415 · MOLLRING MULTITASC
Download PDF FDA Summary LeMaitre Vascular, In…