PROTOS BLOOD TRANSFUSION SET— 510(k) K972843

Clearance details

Applicant

Globe Ent., Inc.

Product code

Code BRZ

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

1997-08-01

Decision date

1997-12-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Houston, TX, US

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• K972839 — PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET1997-12-17
• K972854 — PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY1997-12-17
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• K884622 — SURGICAL GLOVES1989-03-14

Malfunction

458

Total

458

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 →