ACUITY STEERABLE STYLET ACCESSORY— 510(k) K053019

Substantially Equivalent

Guidant Corporation

FDA 510(k) clearance K053019 for ACUITY STEERABLE STYLET ACCESSORY, Substantially Equivalent on 2006-03-03. Applicant: Guidant Corporation.

Clearance details

Applicant: Guidant Corporation
Product code: Code DRB
Advisory panel: Cardiovascular
Date received: 2005-10-26
Decision date: 2006-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Paul, MN, US

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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.