NOVOSTE VESSEL DILATER— 510(k) K912050

Substantially Equivalent

Novaste Corp.

FDA 510(k) clearance K912050 for NOVOSTE VESSEL DILATER, Substantially Equivalent on 1991-10-09. Applicant: Novaste Corp..

Clearance details

Applicant: Novaste Corp.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 1991-05-09
Decision date: 1991-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aguadilla, PR, US

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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.