FDA.reportPublic FDA data

TriGuide Guiding Catheter

Primary DI
00857136004347
Brand
TriGuide Guiding Catheter
Company
SUREFIRE MEDICAL, INC.
Model
TGC-58065-Sim1
Device description
"65cm 0.058"" ID 6F Guide Catheter w/ Sim1 Shape"
Published
2025-11-26
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
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233858000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233858000TriSalus TriGuideTM Guiding CatheterTrisalus Life Sciences2023-12-27DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857136004347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857136004347008571360043478571360043470857136004347

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Catheter Inner Diameter0.058Inch
Catheter Working Length65Centimeter

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
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
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
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
00884450419922SureCrossMerit Medical Systems, Inc.DQY2026-07-24
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
06934955914713Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914720Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914737Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914744Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914751Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914768Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914775Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914782Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914799Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914805Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914812Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914829Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914836Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914843Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914850Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914867Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914874Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914881Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914898Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914904Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914911Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914928Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
00810024671885CPS Locator 3D, Small Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671892CPS Locator 3D, Medium Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671908CPS Locator 3D, Large Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
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008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALDQY2026-07-08