DeviceClearance

IV FLUID TRANSFER PIN— 510(k) K925401

Substantially Equivalent

B. Braun of America, Inc.

FDA 510(k) clearance K925401 for IV FLUID TRANSFER PIN, Substantially Equivalent on 1993-03-03. Applicant: B. Braun of America, Inc.. Device class: 2.

Clearance details

Applicant
B. Braun of America, Inc.
Product code
Code LHI
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bethlehem, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LHI

product code LHI
Injury
207
Malfunction
7,820
Other
3
Total
8,030

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 K925401

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 K925401.

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