B. BRAUN IV START KITS— 510(k) K950184

Name: FDA 510(k) clearance K950184
Creator: U.S. Food and Drug Administration
Published: 1995-03-15

Unknown

B. Braun of America, Inc.

FDA 510(k) clearance K950184 for B. BRAUN IV START KITS, Unknown on 1995-03-15. Applicant: B. Braun of America, Inc.. Device class: 2.

Clearance details

Applicant: B. Braun of America, Inc.
Product code: Code LRS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1995-01-17
Decision date: 1995-03-15
Decision: Unknown
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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K945850 — BRAUN DIACAN(R) FISTULA NEEDLES1995-10-06
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Adverse events under product code LRS

product code LRS

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.