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TrailBlazer™

FDA UDI

Class II (US FDA UDI)

by Ev3, Inc

Identity

Trade Name
TrailBlazer™ FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
PS SC-018-150 TRAILBLAZER V03 FDA UDI
Model / Reference
SC-018-150 FDA UDI
Description
PS SC-018-150 TRAILBLAZER V03 FDA UDI

Identifiers

Primary DI / UDI-DI
00821684058015 FDA UDI
510(k) Number
K092299 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
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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 150.0 Centimeter FDA UDI
Outer Diameter — 0.46 Millimeter FDA UDI

Category: Vascular guide-catheter, single-use

TrailBlazer™ by Ev3, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Cleared under the same submission

K092299 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ev3, Inc

Sources (1)

  • FDA UDI 56dfd3eb-39f2-4b6d-9547-1f986703b1b1 37 fields · synced Jun 1, 2026