B-Capta— 510(k) K202154

Name: FDA 510(k) clearance K202154
Creator: U.S. Food and Drug Administration
Published: 2021-04-01

Substantially Equivalent

Livanova Deutschland, GmbH

FDA 510(k) clearance K202154 for B-Capta, Substantially Equivalent on 2021-04-01. Applicant: Livanova Deutschland, GmbH. Device class: 2.

Clearance details

Applicant: Livanova Deutschland, GmbH
Product code: Code DRY
Device class: Class 2
Regulation: 21 CFR 870.4330
Advisory panel: Cardiovascular
Date received: 2020-08-03
Decision date: 2021-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.