TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)— 510(k) K090973

Substantially Equivalent

Terumo Corp.

FDA 510(k) clearance K090973 for TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES), Substantially Equivalent on 2009-05-01. Applicant: Terumo Corp..

Clearance details

Applicant: Terumo Corp.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2009-04-06
Decision date: 2009-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Elkton, MD, US

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Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.