RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN— 510(k) K011464

Substantially Equivalent

Vascular Intervention

FDA 510(k) clearance K011464 for RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN, Substantially Equivalent on 2001-06-13. Applicant: Vascular Intervention.

Clearance details

Applicant: Vascular Intervention
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2001-05-14
Decision date: 2001-06-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Temecula, CA, 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.