K071227

Substantially Equivalent

CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15

Applicant: Spectranetics Corp.
Product code: PDU
Advisory panel: Cardiovascular
Date received: 2007-05-03
Decision date: 2007-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

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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.