Steripath Gen2 Blood Collection System

Tubes, Vials, Systems, Serum Separators, Blood Collection

Magnolia Medical Technologies, Inc.

The following data is part of a premarket notification filed by Magnolia Medical Technologies, Inc. with the FDA for Steripath Gen2 Blood Collection System.

Pre-market Notification Details

Device IDK192247
510k NumberK192247
Device Name:Steripath Gen2 Blood Collection System
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Magnolia Medical Technologies, Inc. 200 West Mercer Street Suite 500 Seattle,  WA  98119
ContactGregory J Bullington
CorrespondentJohn Ray
Magnolia Medical Technologies, Inc. 200 West Mercer Street Suite 500 Seattle,  WA  98119
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-19
Decision Date2020-02-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858366007313 K192247 000
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10858366007129 K192247 000
10858366007112 K192247 000
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00858366007306 K192247 000
00858366007290 K192247 000
00858366007283 K192247 000
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10858366007044 K192247 000
10858366007037 K192247 000
10858366007020 K192247 000
00858366007016 K192247 000
10858366007150 K192247 000

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