SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING— 510(k) K033843

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K033843 for SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING, Substantially Equivalent on 2004-08-12. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2003-12-10
Decision date: 2004-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

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Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.