MF SAFECATH

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

MediFirst Co., Ltd.

The following data is part of a premarket notification filed by Medifirst Co., Ltd. with the FDA for Mf Safecath.

Pre-market Notification Details

Device IDK192230
510k NumberK192230
Device Name:MF SAFECATH
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant MediFirst Co., Ltd. #1049-16, Charyeonggogae-ro, Gwangdeok-myeon, Dongnam-gu Cheonan-si,  KR 31223
ContactHa Tae Joo
CorrespondentSanglok Lee
Wise Company Inc. #303, 142, Gasan Digital 1-ro Geumcheon-gu,  KR 08301
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-16
Decision Date2020-04-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
28800055100467 K192230 000
28800055100306 K192230 000
28800055100313 K192230 000
28800055100320 K192230 000
28800055100337 K192230 000
28800055100344 K192230 000
28800055100351 K192230 000
28800055100368 K192230 000
28800055100375 K192230 000
28800055100382 K192230 000
28800055100399 K192230 000
28800055100405 K192230 000
28800055100412 K192230 000
28800055100429 K192230 000
28800055100436 K192230 000
28800055100443 K192230 000
28800055100450 K192230 000
28800055100290 K192230 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.