FDA.reportPublic FDA data

Cortex, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30136279703013627970Cortex, Inc.1N2026-01-015455 Great America Parkway Ste 301 Santa Clara CA US 95054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3374321985661219K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)MTD2026-03-13
3374322057359194K251344OptiMap™ SystemDQK2025-05-28
3374321947407564K230008Ablamap® SystemDQK2023-06-08
3374321587374106K223666Ablacath™ Mapping CatheterMTD2023-03-17
3374321348999970
3374321847900217

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MTD22026-03-13
DQK22025-05-28