SPECTRANETICS LLD CS, MODEL 518-039— 510(k) K043401

Name: FDA 510(k) clearance K043401
Creator: U.S. Food and Drug Administration
Published: 2005-03-16

Substantially Equivalent

Spectranetics Corp.

FDA 510(k) clearance K043401 for SPECTRANETICS LLD CS, MODEL 518-039, Substantially Equivalent on 2005-03-16. Applicant: Spectranetics Corp.. Device class: 2.

Clearance details

Applicant: Spectranetics Corp.
Product code: Code DRB
Device class: Class 2
Regulation: 21 CFR 870.1380
Advisory panel: Cardiovascular
Date received: 2004-12-10
Decision date: 2005-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

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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.