Identity
- Trade Name
- Tempo Temporary Pacing Lead, Curved FDA UDI
- Generic Name
- Temporary cardiac pacing balloon catheter FDA UDI
- Device Name
- The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary intracardia 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 fixations, bipolar electrodes and a soft tip. FDA UDI
- Model / Reference
- TC1106 FDA UDI
- Description
- The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary intracardia 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 fixations, bipolar electrodes and a soft tip. FDA UDI
Identifiers
- Catalog Number
- TC1106 FDA UDI
- Primary DI / UDI-DI
- 10866899000210 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 110 Centimeter FDA UDICatheter Gauge — 6 French FDA UDI
Category: Temporary cardiac pacing balloon catheter
Tempo Temporary Pacing Lead, Curved by Biotrace Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Temporary cardiac pacing balloon catheter.
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Cleared under the same submission
K160260 also covers:
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
- Biotrace Medical, Inc.
Sources (1)
- FDA UDI 7d1df49f-4154-4428-90be-f4591e05bdeb 38 fields · synced Jun 7, 2026