510(k) K970608— EVT MARKER BOARD

Substantially Equivalent

Guidant Cardiac and Vascular Surgery

Clearance details

Applicant: Guidant Cardiac and Vascular Surgery
Product code: Code JAA
Advisory panel: Radiology
Date received: 1997-02-18
Decision date: 1997-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.