CENTURION UMBILICAL CATHETER— 510(k) K942353

Name: FDA 510(k) clearance K942353
Creator: U.S. Food and Drug Administration
Published: 1995-08-15

Substantially Equivalent

Tri-State Hospital Supply Corp.

FDA 510(k) clearance K942353 for CENTURION UMBILICAL CATHETER, Substantially Equivalent on 1995-08-15. Applicant: Tri-State Hospital Supply Corp.. Device class: 2.

Clearance details

Applicant: Tri-State Hospital Supply Corp.
Product code: Code FOS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1994-05-17
Decision date: 1995-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Howell, MI, US

Download summary PDF View on FDA.gov ↗

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K945977 — CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING1995-03-29
K931748 — CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS1994-02-25
K935491 — CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)1994-02-17

Adverse events under product code FOS

product code FOS

Death: 12
Other: 1
Total: 13

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.