POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367— 510(k) K964456

Substantially Equivalent

Medtronic Minimed

FDA 510(k) clearance K964456 for POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367, Substantially Equivalent on 1997-01-30. Applicant: Medtronic Minimed.

Clearance details

Applicant: Medtronic Minimed
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1996-11-06
Decision date: 1997-01-30
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.