K052296

Substantially Equivalent

CLIRPATH TURBO EXCIMER LASER CATHETERS

Applicant: Spectranetics Corp.
Product code: PDU
Advisory panel: Cardiovascular
Date received: 2005-08-23
Decision date: 2005-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

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.