MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER— 510(k) K030531

Substantially Equivalent

Minimed, Inc.

FDA 510(k) clearance K030531 for MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER, Substantially Equivalent on 2003-06-17. Applicant: Minimed, Inc..

Clearance details

Applicant: Minimed, Inc.
Product code: Code LZG
Advisory panel: General Hospital
Date received: 2003-02-19
Decision date: 2003-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

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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.