Twin-Pass® 023" dual access catheter

FDA UDI

Class II (US FDA UDI)

by Vascular Solutions, Inc.

Identity

Trade Name: Twin-Pass® 023" dual access catheter FDA UDI
Generic Name: Peripheral vascular intervention infusion catheter FDA UDI
Device Name: The Twin-Pass catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, and for use during two guidewire procedures. The Twin-Pass .023” catheters are also used to sub selectively infuse/deliver diagnostic or therapeutic agents and to measure intra-arterial pressure within the peripheral vasculature. FDA UDI
Model / Reference: 5230 FDA UDI
Description: The Twin-Pass catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, and for use during two guidewire procedures. The Twin-Pass .023” catheters are also used to sub selectively infuse/deliver diagnostic or therapeutic agents and to measure intra-arterial pressure within the peripheral vasculature. FDA UDI

Identifiers

Primary DI / UDI-DI: M20652300 FDA UDI
510(k) Number: K062877 FDA UDI
FDA Product Code: DQO FDA UDI
GMDN Term: Peripheral vascular intervention infusion catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

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Dimensions & Sizes

Size: Length — 135 Centimeter FDA UDI
Catheter Gauge — 4 French FDA UDI

Twin-Pass® 023" dual access catheter by Vascular Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Vascular Solutions, Inc.

Sources (1)

FDA UDI 114cd43e-f55b-4c79-8865-8087072f0632 37 fields · synced May 30, 2026