B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)— 510(k) K103168

Name: FDA 510(k) clearance K103168
Creator: U.S. Food and Drug Administration
Published: 2011-01-06

Substantially Equivalent

Sorin Group Deutschland GmbH

FDA 510(k) clearance K103168 for B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD), Substantially Equivalent on 2011-01-06. Applicant: Sorin Group Deutschland GmbH. Device class: 2.

Clearance details

Applicant: Sorin Group Deutschland GmbH
Product code: Code DRY
Device class: Class 2
Regulation: 21 CFR 870.4330
Advisory panel: Cardiovascular
Date received: 2010-10-27
Decision date: 2011-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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.