SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038— 510(k) K033678

Substantially Equivalent

Spectranetics Corp.

FDA 510(k) clearance K033678 for SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038, Substantially Equivalent on 2004-02-23. Applicant: Spectranetics Corp..

Clearance details

Applicant: Spectranetics Corp.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2003-11-24
Decision date: 2004-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.