MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316— 510(k) K974163

Substantially Equivalent

Medtronic Minimed

FDA 510(k) clearance K974163 for MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316, Substantially Equivalent on 1998-02-02. Applicant: Medtronic Minimed.

Clearance details

Applicant: Medtronic Minimed
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1997-11-05
Decision date: 1998-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.