FDA.reportPublic FDA data

TriNav LV Infusion System

Primary DI
00857136004224
Brand
TriNav LV Infusion System
Company
SUREFIRE MEDICAL, INC.
Model
TVM-25120-50
Device description
"120cm 0.025"" Microcatheter w/ 5.0mm Expandable Tip"
Published
2023-12-05
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
00857136004224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857136004224008571360042248571360042240857136004224

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 Length120Centimeter

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
00857136004293TriNav Advance Infusion SystemADV-38150-352026-09-24
00857136004392TriNav Advance Infusion SystemADV-38115-352026-09-24
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
00857136004231TriNav LV Infusion SystemTVM-25150-502023-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004392TriNav 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
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
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007376Artix™ AXInari Medical, Inc.KRA2023-04-24
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
00763000541194RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541200RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541217RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000399641PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399658PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399665PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26