CRIT-LINE IV SYSTEM— 510(k) K141997

Clearance details

Applicant

Fresenius Medical Care

Product code

Code KOC

Device class

Class 2

Regulation

21 CFR 876.5820

Advisory panel

Gastroenterology, Urology

Date received

2014-07-23

Decision date

2015-04-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Waltham, MA, US

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• K111639 — FRESENIUS 2008T HEMODIALYSIS MACHINE2011-10-21
• K030497 — FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES2003-05-20
• K023162 — FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS2003-03-20
• K022536 — \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR2002-10-30

Death

4

Total

4

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 →