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

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..

Clearance details

Applicant: Biovalve Technologies, Inc.
Product code: Code LZG
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 ↗

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.