Intravascular Extension Sets And Accessories

Set, Administration, Intravascular

Baxter Healthcare Corporation

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

Pre-market Notification Details

Device IDK192366
510k NumberK192366
Device Name:Intravascular Extension Sets And Accessories
ClassificationSet, Administration, Intravascular
Applicant Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake,  IL  60073
ContactGary Chumbimune
CorrespondentGary Chumbimune
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 Received2019-08-30
Decision Date2020-07-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412639395 K192366 000
50085412639333 K192366 000
50085412639357 K192366 000
50085412638831 K192366 000
50085412638848 K192366 000
50085412639340 K192366 000
50085412639418 K192366 000
50085412639425 K192366 000
50085412639449 K192366 000
50085412653285 K192366 000
50085412653292 K192366 000
50085412660382 K192366 000
50085412639364 K192366 000
50085412639388 K192366 000
50085412639326 K192366 000

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