FDA.reportPublic FDA data

TriNav FLX Infusion System

Primary DI
00857136004286
Brand
TriNav FLX Infusion System
Company
SUREFIRE MEDICAL, INC.
Model
FLX-21150-35
Device description
"150cm 0.021"" Microcatheter w/ 1.5-3.5mm Expandable Tip"
Published
2025-04-15
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180677000Surefire Spark Infusion SystemSurefire Medical, Inc.2018-04-03DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857136004286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857136004286008571360042868571360042860857136004286

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge2.4French
Catheter Inner Diameter0.021Inch
Catheter Working Length150Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832575497
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
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
00884450836316Performa®Merit Medical Systems, Inc.DQO2026-10-07
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00884450787793Impress®Merit Medical Systems, Inc.DQO2026-09-18
00884450788868Impress®Merit Medical Systems, Inc.DQO2026-09-18
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
10801902208580ARROWTELEFLEX INCORPORATEDDQO2024-02-05
10801902208542ARROWTELEFLEX INCORPORATEDDQO2023-06-12
10801902208559ARROWTELEFLEX INCORPORATEDDQO2023-06-06
10801902192254ARROWTELEFLEX INCORPORATEDDQO2022-11-29
10801902192285ARROWTELEFLEX INCORPORATEDDQO2022-11-08
00763000541194RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541200RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541217RistTMMicro Therapeutics, Inc.DQO2022-05-01
07290017268347SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268354SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268378SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
00763000413767Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413774Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413781Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413798Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413804Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413811Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413828Rist™Micro Therapeutics, Inc.DQO2020-10-05
10841156105860GREBSETTELEFLEX INCORPORATEDDQO2020-01-27