Cleared Traditional

K081878 - LEMAITRE TT TORTUOUS TRACKER INTRODUCER...

K081878 is the FDA 510(k) clearance for LEMAITRE TT TORTUOUS TRACKER INTRODUCER... by LeMaitre Vascular, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K081878 · LeMaitre Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
209d
Days
Class 2
Risk

K081878 is an FDA 510(k) clearance for the LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on January 27, 2009 after a review of 209 days - an extended review cycle.

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 K081878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2008
Decision Date January 27, 2009
Days to Decision 209 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 125d · This submission: 209d
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 K081878.
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY
K090659 · Medtronic, Inc. · Mar 2009
6F TAIGA GUIDING CATHETER
K083422 · Medtronic Vascular · Feb 2009
ASAHI CORSAIR MICROCATHETER
K083127 · Asahi Intecc Co., Ltd. · Feb 2009
MINNIE SUPPORT CATHETER
K082337 · Vascular Solutions, Inc. · Jan 2009
CONQUEST PTA BALLOON DILATATION CATHETER
K083657 · C.R. Bard, Inc. · Dec 2008
CPS AIM SL SLITTABLE INNER CATHETER
K082932 · St Jude Medical · Dec 2008