2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035— 510(k) K123632

Substantially Equivalent

Spectranetics Corp.

FDA 510(k) clearance K123632 for 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035, Substantially Equivalent on 2013-01-25. Applicant: Spectranetics Corp..

Clearance details

Applicant: Spectranetics Corp.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2012-11-23
Decision date: 2013-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.