FDA.reportPublic FDA data

510(k) K191935

Device
Nautilus Smart ECMO Module
Applicant
MC3 Incorporated
510(k) number
K191935
Product code
BYS  
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-09
Date received
2019-07-19
Regulation
870.4100
Classification name
Oxygenator, Long Term Support Greater Than 6 Hours
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Adam Viitala
Address
2555 Bishop Cir. W Dexter MI US 48130 48130

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BYS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232767Nautilus VF ECMO OxygenatorMc3, Inc.2023-10-04
K770720TUBING PACK, EXTRACORPOREAL, H-3000William Harvey Life Products Corp.1977-08-04

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases