Device Listing 1375218627

Listing Summary

Listing key
1375218627
Premarket submission
K192922
Device
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
Applicant
Gentuity, LLC
Product code
NQQ
Decision date
2020-02-20

Related Registrations

Registration keyRegistrationFEICompanyStatusInitial importerExpirationAddress
26709830115785443011578544GENTUITY, LLC1N2026-01-01142 North Road Suite G Sudbury MA US 01776
30243930216300973021630097GENTUITY, LLC1N2026-01-0128 Crosby Drive Bedford MA US 01730