NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT— 510(k) K033328

Substantially Equivalent

Novosci Corp.

FDA 510(k) clearance K033328 for NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT, Substantially Equivalent on 2004-01-16. Applicant: Novosci Corp..

Clearance details

Applicant: Novosci Corp.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2003-10-16
Decision date: 2004-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Woodlands, TX, US

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.