510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081878Substantially Equivalent

Lemaitre Tt Tortuous Tracker Introducer Catheter Delivery System

LeMaitre Vascular Inc., Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K081878 is the FDA 510(k) clearance record for LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM, a class II device, cleared for LeMaitre Vascular, Inc. on under FDA product code DQY (Catheter, Percutaneous). FDA records list 35 510(k) clearances for LeMaitre Vascular, Inc., from to . As of , FDA records show no recalls naming K081878.

Clearance record

Decision date
Received
(209 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
LeMaitre Vascular, Inc. 63 Second Ave., Burlington MA
510(k) summary
Statement
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260