ANGIOCATH SIDEHOLDER DRAINAGE CATHETER— 510(k) K950437

Name: FDA 510(k) clearance K950437
Creator: U.S. Food and Drug Administration
Published: 1995-03-14

Substantially Equivalent

Becton Dickinson Vascular Access, Inc.

FDA 510(k) clearance K950437 for ANGIOCATH SIDEHOLDER DRAINAGE CATHETER, Substantially Equivalent on 1995-03-14. Applicant: Becton Dickinson Vascular Access, Inc.. Device class: 1.

Clearance details

Applicant: Becton Dickinson Vascular Access, Inc.
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1995-02-02
Decision date: 1995-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandy, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.