Paclitaxel Sets

Set, Administration, Intravascular

BAXTER HEALTHCARE CORPORATION

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Paclitaxel Sets.

Pre-market Notification Details

Device IDK160007
510k NumberK160007
Device Name:Paclitaxel Sets
ClassificationSet, Administration, Intravascular
Applicant BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake,  IL  60073
ContactTiffany Lin
CorrespondentTiffany Lin
BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake,  IL  60073
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-04
Decision Date2016-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412565779 K160007 000
50085412071683 K160007 000
50085412046377 K160007 000
50085412036385 K160007 000
50085412036378 K160007 000

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