FDA.reportPublic FDA data

EBR SYSTEMS INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30135967423013596742EBR SYSTEMS INC.1N2026-01-01480 Oakmead Pkwy Sunnyvale CA US 94085
30443227163044322716EBR SYSTEMS INC.1N2026-01-014600 Patrick Henry Dr Santa Clara CA US 95054

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00859244007005WiSE CRT System - Transmitter4087201906ebr.ra@ebrwise.com
00859244007029WiSE CRT System - Battery4087201906ebr.ra@ebrwise.com
00859244007043WiSE CRT System - Receiver Electrode Delivery Catheter4087201906ebr.ra@ebrwise.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3370701528177561P240028WiSE® (Wireless Stimulation of the Endocardium Technology) CRT SystemSEG2025-04-11
3487651528177561P240028WiSE® (Wireless Stimulation of the Endocardium Technology) CRT SystemSEG2025-04-11
3370701724632288K792558CONTAINER SYSTEMFLE1979-12-27
3487651724632288K792558CONTAINER SYSTEMFLE1979-12-27
3370701336015043K053389AESCULAP STERILCONTAINER SYSTEMFRG2006-02-15
3487651336015043K053389AESCULAP STERILCONTAINER SYSTEMFRG2006-02-15
3370701015399155
3487651015399155
3370701396086988
3487651396086988
3370701649441527
3487651649441527
3370701726997383
3487651726997383

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRG22006-02-15
FLE21979-12-27

GUDID#