HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R

System, Peritoneal, Automatic Delivery

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Homechoice/homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5c4471, 5c8310, 5c4471r And 5c8310r.

Pre-market Notification Details

Device IDK102936
510k NumberK102936
Device Name:HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
ClassificationSystem, Peritoneal, Automatic Delivery
Applicant BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD. Mcgaw Park,  IL  60085
ContactDavid E Curtin
CorrespondentDavid E Curtin
BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD. Mcgaw Park,  IL  60085
Product CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-04
Decision Date2011-03-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412090073 K102936 000
50085412088438 K102936 000
50085412087677 K102936 000
00085412079165 K102936 000
00085412026350 K102936 000
00085412007038 K102936 000
00085412007021 K102936 000

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