DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Cook, Inc.
Product code
Code FOZ
Device class
Class 2
Regulation
21 CFR 880.5200
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bloomington, IN, US
Download summary PDFView on FDA.gov ↗

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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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K033843

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033843.

Data sourced from openFDA. This site is unofficial and independent of the FDA.