BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)— 510(k) K050971

Name: FDA 510(k) clearance K050971
Creator: U.S. Food and Drug Administration
Published: 2005-08-16

Substantially Equivalent

Biovalve Technologies, Inc.

FDA 510(k) clearance K050971 for BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS), Substantially Equivalent on 2005-08-16. Applicant: Biovalve Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Biovalve Technologies, Inc.
Product code: Code LZG
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2005-04-18
Decision date: 2005-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZG

product code LZG

Death: 104
Injury: 12,022
Malfunction: 135,004
Other: 1
Total: 147,131

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.