Duns Number:044674446
Device Description: The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary intracardiac pa 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.
Catalog Number
T1106
Brand Name
Tempo Temporary Pacing Lead
Version/Model Number
T1106
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160260
Product Code
LDF
Product Code Name
Electrode, Pacemaker, Temporary
Public Device Record Key
131c5104-5225-4f08-bcee-2ac02883aeb0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |