Aspiron(TM) Aspiration Catheter— 510(k) K190619

Name: FDA 510(k) clearance K190619
Creator: U.S. Food and Drug Administration
Published: 2019-04-29

Substantially Equivalent

Meril Life Sciences Private Limited

FDA 510(k) clearance K190619 for Aspiron(TM) Aspiration Catheter, Substantially Equivalent on 2019-04-29. Applicant: Meril Life Sciences Private Limited. Device class: 2.

Clearance details

Applicant: Meril Life Sciences Private Limited
Product code: Code QEZ
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2019-03-11
Decision date: 2019-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vapi, IN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

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.