LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM— 510(k) K081878

Name: FDA 510(k) clearance K081878
Creator: U.S. Food and Drug Administration
Published: 2009-01-27

Substantially Equivalent

LeMaitre Vascular, Inc.

FDA 510(k) clearance K081878 for LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM, Substantially Equivalent on 2009-01-27. Applicant: LeMaitre Vascular, Inc.. Device class: 2.

Clearance details

Applicant: LeMaitre Vascular, Inc.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2008-07-02
Decision date: 2009-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQY

view all

K260559 — NHanceIT2026-08-14
K262392 — APRO 35 Swift Catheter2026-08-12
K261766 — CPS Locator 3D Plus Delivery Catheter2026-07-29
K262240 — SSPC NXT Delivery Catheter2026-07-29
K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02

More clearances from LeMaitre Vascular, Inc.

view all

K212894 — PhasTIPP2022-03-31
K183513 — XenoSure Dura Biologic Patch2019-06-13
K173323 — AnastoClip GC Closure System2018-03-08
K152833 — Pruitt F3-S Polyurethane Carotid Shunt2016-01-21
K143454 — Pruitt F3-S Carotid Shunt2015-08-27

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.