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
10858366007051 K192247 000
00858366007276 K192247 000
00858366007306 K192247 000
00858366007016 K192247 000
10858366007020 K192247 000
10858366007037 K192247 000
10858366007044 K192247 000
10858366007198 K192247 000
10858366007204 K192247 000
00858366007283 K192247 000
00858366007290 K192247 000
10858366007006 K192247 000

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