MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300— 510(k) K970479

Substantially Equivalent

Medtronic Minimed

FDA 510(k) clearance K970479 for MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300, Substantially Equivalent on 1997-03-31. Applicant: Medtronic Minimed.

Clearance details

Applicant: Medtronic Minimed
Product code: Code KZH
Advisory panel: General Hospital
Date received: 1997-02-07
Decision date: 1997-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.