Cleared Traditional

K121415 - MOLLRING MULTITASC

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

K121415 · LeMaitre Vascular, Inc. · Cardiovascular device
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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.

View all LeMaitre Vascular, Inc. devices

Submission Details

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
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.

Device Classification

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

Devices cleared under the same product code (DWX) and FDA review panel - the closest regulatory comparables to K121415.
EXTERNAL VEIN STRIPPER
K933498 · Applied Medical Resources · Mar 1994
MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE
K911099 · Pilling Co. · Jun 1991
TRANSLUMINAL ENDARTERECTOMY DEVICE
K904944 · Baxter Healthcare Corp · Dec 1990
OLYMPUS VALVULOTOME W/DETACHABLE TIP
K895878 · Olympus Corp. · Jan 1990
OLYMPUS VALVULOTOME W/FIXED TIP
K894496 · Olympus Corp. · Oct 1989
HALL ARTERIAL OSCILLATOR
K801063 · American Sterilizer Co. · Sep 1980