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GuideLiner® Navigation™ catheter

FDA UDI

Class II (US FDA UDI)

by Vascular Solutions, Inc.

Identity

Trade Name
GuideLiner® Navigation™ catheter FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
Navigation catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of guidewires and other interventional devices. FDA UDI
Model / Reference
5472 FDA UDI
Description
Navigation catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of guidewires and other interventional devices. FDA UDI

Identifiers

Primary DI / UDI-DI
M20654720 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
Catheter Gauge — 7 French FDA UDI

GuideLiner® Navigation™ 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

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Manufacturer

Manufacturer
Vascular Solutions, Inc.

Sources (1)

  • FDA UDI 72670901-e4ae-476c-a138-5cb5d88b0c41 36 fields · synced May 31, 2026