K052965

Substantially Equivalent

EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.

Applicant: Guidant Corporation
Product code: DRB
Advisory panel: Cardiovascular
Date received: 2005-10-21
Decision date: 2006-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Paul, MN, US

Adverse events under product code DRB

product code DRB

Death: 36
Injury: 562
Total: 598

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.