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Surefire Medical, Inc.: FDA-registered device maker in Westminster, CO, United States, 5 510(k) clearances

Name: Surefire Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Surefire Medical, Inc. is registered with the FDA (registration 3010909876) in Westminster, CO, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 21, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010909876
Address: 6272 W 91st Ave, Westminster, CO, United States, 80031
Owner or operator: TriSalus Life Sciences (10038066)
Roles: Complaint file establishment, Manufacturer
First device listed: July 18, 2018
Registered through: 2026
Brand names listed: Spark Infusion System, TriNav FLX Infusion System, TriNav Infusion System, TriSalus Infusion System, TriSalus TriGuideTM Guiding Catheter, TriSalus TriNav® Advance Infusion System, TriSalus TriNav® LV Infusion System, TriSalus TriNav® XP Infusion System

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Continuous Flush	KRA	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 21, 2026	K253509	TriSalus TriNav Advance Infusion System	KRA	Substantially Equivalent	Trisalus Life Sciences	accessdata.fda.gov
December 27, 2023	K233858	TriSalus TriGuideTM Guiding Catheter	DQY	Substantially Equivalent	Trisalus Life Sciences	accessdata.fda.gov
May 2, 2023	K230957	TriSalus TriNav® LV Infusion System	KRA	Substantially Equivalent	Trisalus Life Sciences	accessdata.fda.gov
December 3, 2019	K193107	TriSalus Infusion System	KRA	Substantially Equivalent	Trisalus Life Sciences	accessdata.fda.gov
April 3, 2018	K180677	Surefire Spark Infusion System	DQO	Substantially Equivalent	Surefire Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.