FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

INTERNATIONAL BIOPHYSICS CORPORATION

The following data is part of a premarket notification filed by International Biophysics Corporation with the FDA for Flopump 32ml, Sterile, Flopump 32ml, Non-sterile.

Pre-market Notification Details

Device IDK170029
510k NumberK170029
Device Name:FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant INTERNATIONAL BIOPHYSICS CORPORATION 2101 E. ST. ELMO ROAD Austin,  TX  78744
ContactGeoff Marcek
CorrespondentGeoff Marcek
INTERNATIONAL BIOPHYSICS CORPORATION 2101 E. ST. ELMO ROAD Austin,  TX  78744
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-04
Decision Date2017-12-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814321020148 K170029 000
00814321020131 K170029 000

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