LEXIPLIANT DILATOR SHEATH SET— 510(k) K133631

Substantially Equivalent

Spectranetics Corporation

FDA 510(k) clearance K133631 for LEXIPLIANT DILATOR SHEATH SET, Substantially Equivalent on 2014-03-27. Applicant: Spectranetics Corporation.

Clearance details

Applicant: Spectranetics Corporation
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2013-11-26
Decision date: 2014-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.