FDA.reportPublic FDA data

Mi-EXT Distal Access Catheter

Primary DI
B293MIEXT57250
Brand
Mi-EXT Distal Access Catheter
Company
MIVI NEUROVASCULAR
Model
Mi-EXT-5725
Device description
The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion of angiographic visualization. The catheter shaft has a hydrophilic coating. The proximal portion of the catheter is a stainless-steel control wire.
Published
2017-06-01
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

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163233000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163233000MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension CatheterMivi Neuroscience, Inc.2017-04-06DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B293MIEXT57250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, 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), 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 of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Length142Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Dry and dark

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
076836823
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B293MCK15000MIVI Canister KitMCK-15002017-03-21
B293MIA571120Mi-Axus CatheterMIA-571122016-09-19
B293MIA571300Mi-Axus CatheterMIA-571302016-09-19
B293MIA90800Mi-Axus CatheterMIA90802016-09-28
B293MIA9080S0Mi-Axus CatheterMIA9080S2017-03-15
B293MIA90900Mi-Axus CatheterMIA90902016-09-28
B293MIA9090S0Mi-Axus CatheterMIA9090S2017-03-15
B293MIA9095S0Mi-Axus CatheterMIA9095S2018-02-23
B293MIEXT36370Mi-EXT Distal Access CatheterMi-EXT-36372017-06-01
B293MIEXT43300Mi-EXT Distal Access CatheterMi-EXT-43302017-06-01
B293MIEXT69250Mi-EXT Distal Access CatheterMi-EXT-69252017-06-01
B293MIEXT6925U0Mi-EXT Distal Access CatheterMi-EXT-6925U2017-09-20
B293Q3361630Q Distal Access CatheterQ3-361632018-07-31
B293Q4431500Q Distal Access CatheterQ4-431502018-12-06
B293Q5571450Q Distal Access CatheterQ5-571452018-12-06
B293Q6691450Q Distal Access CatheterQ6-691452018-07-31
B293HFT1100MIVI High Flow TubingHFT1102017-01-05
B293VR014205G0Vi-RadiusVR014205G2016-09-28
B293VR014300G0Vi-RadiusVR014300G2016-09-28

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