DeviceClearance

COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS— 510(k) K081113

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K081113 for COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS, Substantially Equivalent on 2008-07-30. 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 K081113

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 K081113.

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