D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW— 510(k) K063355

Unknown

Novosci Corp.

FDA 510(k) clearance K063355 for D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW, Unknown on 2007-07-27. Applicant: Novosci Corp..

Clearance details

Applicant: Novosci Corp.
Product code: Code MPB
Advisory panel: Gastroenterology, Urology
Date received: 2006-11-07
Decision date: 2007-07-27
Decision: Unknown
Clearance type: Traditional
Location: The Woodlands, TX, US

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Adverse events under product code MPB

product code MPB

Death: 18
Malfunction: 1,042
Total: 1,060

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.