MULTILUMEN CENTRAL VENOUS CATHETER— 510(k) K885221

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K885221 for MULTILUMEN CENTRAL VENOUS CATHETER, Substantially Equivalent on 1989-12-28. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code
Code DQO
Device class
Class 2
Regulation
21 CFR 870.1200
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sandy, UT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DQO

product code DQO
Death
35
Injury
993
Malfunction
1,772
Other
5
Total
2,805

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 →

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