LLD EZ— 510(k) K142116

Substantially Equivalent

Spectranetics, Inc.

FDA 510(k) clearance K142116 for LLD EZ, Substantially Equivalent on 2014-08-12. Applicant: Spectranetics, Inc..

Clearance details

Applicant: Spectranetics, Inc.
Product code: Code DRB
Advisory panel: Cardiovascular
Date received: 2014-08-04
Decision date: 2014-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Colorado Springs, CO, 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.