DARDIK CAROTID SHUNT— 510(k) K001621

Name: FDA 510(k) clearance K001621
Creator: U.S. Food and Drug Administration
Published: 2000-12-06

Substantially Equivalent

Vascutech, Inc.

FDA 510(k) clearance K001621 for DARDIK CAROTID SHUNT, Substantially Equivalent on 2000-12-06. Applicant: Vascutech, Inc.. Device class: 2.

Clearance details

Applicant: Vascutech, Inc.
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 2000-05-26
Decision date: 2000-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

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K992940 — LEMAITRE BALLOON CATHETER WITH IRRIGATION2000-02-22
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Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.