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Mi-EXT Distal Access Catheter

FDA UDI

Class II (US FDA UDI)

by Mivi Neurovascular

Identity

Trade Name
Mi-EXT Distal Access Catheter FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
Mi-EXT-5725 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
B293MIEXT57250 FDA UDI
510(k) Number
K163233 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 142 Centimeter FDA UDI
Catheter Gauge — 5 French FDA UDI

Mi-EXT Distal Access Catheter by Mivi Neurovascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K163233 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mivi Neurovascular

Sources (1)

  • FDA UDI d409a129-700e-4346-9b99-e7f370399e40 37 fields · synced May 30, 2026