FDA.reportPublic FDA data

TriNav Advance Infusion System

Primary DI
00857136004392
Brand
TriNav Advance Infusion System
Company
SUREFIRE MEDICAL, INC.
Model
ADV-38115-35
Device description
115cm 0.038" Microcatheter w/ 3.5mm Expandable Valve
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253509000TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences2026-09-21KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857136004392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857136004392008571360043928571360043920857136004392

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Catheter Inner Diameter0
Catheter Working Length0

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
832575497
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857136004293TriNav Advance Infusion SystemADV-38150-352026-09-24
00857136004408TriNav Advance Infusion SystemADV-38095-502026-09-24
00857136004415TriNav Advance Infusion SystemADV-38095-352026-09-24
00857136004330TriGuide Guiding CatheterTGC-58065-Axis2025-11-26
00857136004347TriGuide Guiding CatheterTGC-58065-Sim12025-11-26
00857136004354TriGuide Guiding CatheterTGC-58065-Cobra2025-11-26
00857136004248TriGuide Guiding CatheterTGC-48065-Axis2024-08-09
00857136004255TriGuide Guiding CatheterTGC-48065-Sim12024-08-09
00857136004262TriGuide Guiding CatheterTGC-48065-Cobra2024-08-09
00857136004057Surefire Guiding CatheterSGC-5065-Cobra12016-09-08
00857136004064Surefire Guiding CatheterSGC-5065-Sim12016-09-08
00857136004071Surefire Guiding CatheterSGC-5065-Axis2016-09-08
00857136004149Surefire Flexion Guiding CatheterSSG-5080-Axis2017-02-07
00857136004156Surefire Flexion Guiding CatheterSSG-5080-Sim12017-02-07
00857136004316TriNav XP Infusion SystemXPS-25130-352025-09-29
00857136004323TriNav XP Infusion SystemXPS-25150-352025-09-29
00857136004279TriNav FLX Infusion SystemFLX-21120-352025-04-15
00857136004286TriNav FLX Infusion SystemFLX-21150-352025-04-15
00857136004224TriNav LV Infusion SystemTVM-25120-502023-12-05
00857136004231TriNav LV Infusion SystemTVM-25150-502023-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
00884450836316Performa®Merit Medical Systems, Inc.DQO2026-10-07
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-09-29
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00884450787793Impress®Merit Medical Systems, Inc.DQO2026-09-18
00884450788868Impress®Merit Medical Systems, Inc.DQO2026-09-18
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.KRA2025-04-09
00810123710577Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-11
00810123710560Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-07
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
B0902P0130B0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B0902P0130S0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B090E20130B0XO CathZien Medical Technologies, LLCKRA2024-04-30
B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
00810123710140ClotTriever CatheterInari Medical, Inc.KRA2024-04-17
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.KRA2024-03-27
00810123710430ClotTriever SheathInari Medical, Inc.KRA2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00850291007369InThrill SheathInari Medical, Inc.KRA2023-07-18
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09