Coapt, LLC - Nov. 2, 2022
Issue Date
Nov 02, 2022
Region
Central
Category
Device
$117.00
Contact Name
Blair A. Lock
Contact Title
Chief Executive Officer
Address 1
303 W. Institute Pl.
Address 2
Ste. 200
City
Chicago
State
IL
Zip/Postal Code
60610-3080
Inspection Range
Oct 28, 2022 - Nov 02, 2022
Pages
4
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Brittani N. Franklin