EverCrossTM 0.035 OTW PTA Dilatation Catheter— 510(k) K190753

Name: FDA 510(k) clearance K190753
Creator: U.S. Food and Drug Administration
Published: 2019-04-23

Substantially Equivalent

Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)

FDA 510(k) clearance K190753 for EverCrossTM 0.035 OTW PTA Dilatation Catheter, Substantially Equivalent on 2019-04-23. Applicant: Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.). Device class: 2.

Clearance details

Applicant: Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2019-03-25
Decision date: 2019-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter +5 more2025-04-04

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.