MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT— 510(k) K133807

Clearance details

Applicant

Gambro Renal Products, Inc.

Product code

Code FLD

Device class

Class 2

Regulation

21 CFR 876.5870

Advisory panel

Gastroenterology, Urology

Date received

2013-12-16

Decision date

2014-03-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lakewood, CO, US

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• K110823 — PRISMAFLEX2011-06-17
• K103832 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM2011-05-20
• K100451 — GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-1322010-12-21

• Z-0411-2018 — MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541Class II·Terminated·Baxter Healthcare Corporation·20171221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133807.