RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder— 510(k) K173279

Clearance details

Applicant

Myco Medical Supplies, Inc.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

2017-10-13

Decision date

2018-05-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Apex, NC, US

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• K042504 — CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER2006-01-19
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• K990519 — PHOENIX EPIDURAL & SPINAL NEEDLES2000-06-02

Death

28

Injury

1,517

Malfunction

23,981

Other

18

Total

25,544

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 →