FDA.reportPublic FDA data

SmartNeedle® vascular access system

Primary DI
M206780400
Brand
SmartNeedle® vascular access system
Company
Vascular Solutions, Inc.
Model
78040
Device description
Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.
Published
2016-09-06
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
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M206780401PackageHIBCC10In Commercial Distribution
M206780400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, battery-poweredA hand-held, battery-powered device assembly consisting of a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis, and the vascular states of partially severed extremities), ankle pressure index, and/or blood flow wave form recording.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge20Gauge

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
M20679600VSI StraitSet™ micro-introducer kit79602018-08-09
M20679610VSI StraitSet™ micro-introducer kit79612018-08-09
M20679620VSI StraitSet™ micro-introducer kit79602018-08-09
M20679640VSI StraitSet™ micro-introducer kit79602018-08-09
M20679650VSI StraitSet™ micro-introducer kit79612018-08-09
M20679710VSI StraitSet™ micro-introducer kit79612018-08-09
M206780500SmartNeedle® vascular access system780502016-09-06
M206780600SmartNeedle® vascular access system780602016-09-06
M206780300SmartNeedle® vascular access system780302016-09-05
M206720000SmartNeedle® monitor720002016-09-23
M20631010Thrombix® Hemostasis Patch topical hemostat31012016-09-15
M20630100D-Stat® 2 Dry topical hemostat30102016-09-15
M20681500Teirstein Edge™ device organizer81502016-09-05
M20681510Angio Assist™ docking station81512016-09-05
M20673710Axis™ guidewire73712016-09-05
M20673720Axis™ guidewire73722016-09-05
M20674720VSI Tru-Torque™ guidewire74722016-09-05
M20674730VSI Tru-Torque™ guidewire74732016-09-05
M20674790Amplatz SST™ guidewire74792016-09-05
M20674820Amplatz SST™ guidewire74822016-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
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00841436127028Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436127035Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125311CIV-Clear™ Transducer CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125915Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
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10841436127056Cable SleeveCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127186Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
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00841436126656Multi-Purpose Workstation ™ StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
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