MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX— 510(k) K960631

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K960631 for MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX, Substantially Equivalent on 1996-05-21. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code GZF
Advisory panel: Neurology
Date received: 1996-02-14
Decision date: 1996-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code GZF

product code GZF

Death: 10
Injury: 2,410
Other: 1
Total: 2,421

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.