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FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Temporary cardiac pacing balloon catheter FDA UDI
Device Name
Double-Lumen Balloon Wedge Pressure Catheter FDA UDI
Model / Reference
IPN000054 FDA UDI
Description
Double-Lumen Balloon Wedge Pressure Catheter FDA UDI

Identifiers

Catalog Number
AI-07025 FDA UDI
Primary DI / UDI-DI
00801902004345 FDA UDI
510(k) Number
K892530 FDA UDI
FDA Product Code
DYG FDA UDI
GMDN Term
Temporary cardiac pacing balloon catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1240 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

Yes

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 — 5 French FDA UDI
Length — 80 Centimeter FDA UDI

Category: Temporary cardiac pacing balloon catheter

Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temporary cardiac pacing balloon catheter.

Cleared under the same submission

K892530 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI be4a927d-77ef-4b8e-8c43-b9b5fa0e50ae 38 fields · synced May 30, 2026