K043401

Substantially Equivalent

SPECTRANETICS LLD CS, MODEL 518-039

Applicant: Spectranetics Corp.
Product code: DRB
Advisory panel: Cardiovascular
Date received: 2004-12-10
Decision date: 2005-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, 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.