K990333

Substantially Equivalent

MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015

Applicant: Medtronic PS Medical
Product code: GWG
Advisory panel: Neurology
Date received: 1999-02-03
Decision date: 1999-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.