FDA.reportPublic FDA data

Surefire Medical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30109098763010909876Surefire Medical, Inc.1N2026-01-016272 W 91st Ave Westminster CO US 80031

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1752361111752054K233858TriSalus TriGuideTM Guiding CatheterDQY2023-12-27
1752361606608250K230957TriSalus TriNav® LV Infusion SystemKRA2023-05-02
1752361361008226K193107TriSalus Infusion SystemKRA2019-12-03
1752361218479967K180677Surefire Spark Infusion SystemDQO2018-04-03
1752361119693266K162359Surefire Guiding CatheterDQY2016-09-21
1752361516360787K140034SUREFIRE GUIDING CATHETERDQY2014-02-26
1752361047234049K121677SUREFIRE HI-FLOW MICROCATHETERDQO2012-06-14
1752361694355383

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY32023-12-27
KRA22023-05-02
DQO22018-04-03

PMN#

GUDID#