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Tempo Temporary Pacing Lead

FDA UDI

Class II (US FDA UDI)

by Biotrace Medical, Inc.

Identity

Trade Name
Tempo Temporary Pacing Lead FDA UDI
Generic Name
Temporary cardiac pacing balloon catheter FDA UDI
Device Name
The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary intracardiac pacing. The lead provides access to the right ventricle via either the femoral vein, subclavian vein or the internal jugular vein approach and may be shaped near the distal end to facilitate delivery. It is a radiopaque, polymeric lead featuring a balloon, active fixation, bipolar electrodes and a soft tip. FDA UDI
Model / Reference
T1106 FDA UDI
Description
The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary intracardiac pacing. The lead provides access to the right ventricle via either the femoral vein, subclavian vein or the internal jugular vein approach and may be shaped near the distal end to facilitate delivery. It is a radiopaque, polymeric lead featuring a balloon, active fixation, bipolar electrodes and a soft tip. FDA UDI

Identifiers

Catalog Number
T1106 FDA UDI
Primary DI / UDI-DI
10866899000203 FDA UDI
510(k) Number
K160260 FDA UDI
FDA Product Code
LDF FDA UDI
GMDN Term
Temporary cardiac pacing balloon catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3680 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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 6 French FDA UDI
Length — 110 Centimeter FDA UDI

Category: Temporary cardiac pacing balloon catheter

Tempo Temporary Pacing Lead by Biotrace Medical, Inc. — 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

K160260 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biotrace Medical, Inc.

Sources (1)

  • FDA UDI 131c5104-5225-4f08-bcee-2ac02883aeb0 38 fields · synced May 30, 2026