CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER— 510(k) K141363

Clearance details

Applicant

Merit Medical Systems, Inc.

Product code

Code MSD

Device class

Class 2

Regulation

21 CFR 876.5540

Advisory panel

Gastroenterology, Urology

Date received

2014-05-23

Decision date

2014-06-18

Decision

Unknown

Clearance type

Special

Location

South Jordan, UT, US

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Death

67

Injury

545

Malfunction

3,661

Total

4,273

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 →