FDA.reportPublic FDA data

Octane™

Primary DI
M20650720
Brand
Octane™
Company
Vascular Solutions, Inc.
Model
5072
Published
2018-01-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXECatheter, Embolectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20650720PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter to obtain blood samples. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-240-6001customerservice@vasc.com

Regulatory Flags#

DUNS number
008999906
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M20655660TrapLiner™ catheter55662017-02-07
M20655680TrapLiner™ catheter55682017-02-07
M20655670TrapLiner™ catheter55672017-02-07
M20655690GuideLiner® V3 catheter55692016-09-05
M20655700GuideLiner® V3 catheter55702016-09-05
M20655710GuideLiner® V3 catheter55712016-09-05
M20655720GuideLiner® V3 catheter55722016-09-05
M20655730GuideLiner® V3 catheter55732016-09-05
M20656210Turnpike® Gold catheter56212016-09-05
M20656220Turnpike® Gold catheter56222016-09-05
M20656380Turnpike® LP catheter56382016-09-05
M20656390Turnpike® LP catheter56392016-09-05
M20656400Turnpike® Spiral catheter56402016-09-05
M20656410Turnpike® Spiral catheter56412016-09-05
M20656420Turnpike® catheter56422016-09-05
M20656430Turnpike® catheter56432016-09-05
M20654700GuideLiner® Navigation™ catheter54702016-09-05
M20654710GuideLiner® Navigation™ catheter54712016-09-05
M20654720GuideLiner® Navigation™ catheter54722016-09-05
M20654730GuideLiner® Navigation™ catheter54732016-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076916008LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916015LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916022LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916039LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916046LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916053LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916060LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916077LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916084LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916091LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916107LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916114LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916121LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916855LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00885403530374Fogarty CorkscrewBecton, Dickinson And CompanyDXE2026-09-04
00885403530381Fogarty CorkscrewBecton, Dickinson And CompanyDXE2026-09-04
00885403530398Fogarty CorkscrewBecton, Dickinson And CompanyDXE2026-09-04
00884450466995Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-27
00884450466988Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-25
00884450467008Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-25
00885403530534FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyDXE2026-08-14
00885403530404FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530411FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530428FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530442FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530466FogartyBecton, Dickinson And CompanyDXE2026-07-31