DeviceClearance

VACUTAINER PLUS WITH HEMOGARD CLOSURE— 510(k) K901449

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K901449 for VACUTAINER PLUS WITH HEMOGARD CLOSURE, Substantially Equivalent on 1990-08-09. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code
Code JKA
Device class
Class 2
Regulation
21 CFR 862.1675
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Franklin Lakes, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JKA

product code JKA
Injury
455
Malfunction
26,686
Other
4
Total
27,145

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 K901449

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 K901449.

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