FDA.reportPublic FDA data

TriNav XP Infusion System

Primary DI
00857136004316
Brand
TriNav XP Infusion System
Company
SUREFIRE MEDICAL, INC.
Model
XPS-25130-35
Device description
"130cm 0.025"" Microcatheter w/ 3.5mm Expandable Tip"
Published
2025-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K230957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230957000TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences2023-05-02KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857136004316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857136004316008571360043168571360043160857136004316

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 Gauge2.9French
Catheter Inner Diameter0.025Inch
Catheter Working Length130Centimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
832575497
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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 Catheter TGC-48065-Cobra2024-08-09
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
00857136004194TriSalus Infusion SystemTIS-21120-602020-01-31
00857136004200TriNav Infusion SystemTNV-21150-352020-01-01
00857136004217TriNav Infusion SystemTNV-21120-352020-01-01
00857136004187Surefire Spark Infusion SystemSPARK-A1202019-09-17
00857136004019Surefire Infusion SystemSHF-38120-LT2016-09-08
00857136004040Surefire Infusion SystemSHF-38120-mT2016-09-08
00857136004088Surefire Precision Infusion SystemSPS-21120-352016-09-08
00857136004095Surefire Precision Infusion SystemSPS-21150-352016-09-08
00857136004101Surefire Precision Infusion SystemSPS-25120-402016-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450826560Fountain®Merit Medical Systems, Inc.KRA2026-06-09
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08
00191506067342TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067359TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067366TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067373TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067380TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067397TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067403TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067410TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522348SWAN-GANZ CCOMBO VBecton, Dickinson And CompanyKRA2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403523819VAMPBecton, Dickinson And CompanyKRA2026-05-30
00884450826492Fountain®Merit Medical Systems, Inc.KRA2026-05-29
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023825Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023832Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023849Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023856Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023863Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023870Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023887Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023894Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023900Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023924Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01