Duns Number:439770017
Device Description: The ST-ADPT-30 adapter cable is an accessory for the SENSITHERM MULTI system that can b The ST-ADPT-30 adapter cable is an accessory for the SENSITHERM MULTI system that can be inserted in a dedicated socket on the handle of the ST-PTCBL patient cable for connecting the conductive terminals of ST -Probe to a mapping system.At one end, the adapter cable is equipped with a custom plug compatible with the dedicated port in the patient cable. The other end of the cable contains seven single pole polyurethane cables, each one ending in a 2mm touch-proof plug compatible with the input ports of a mapping system.
Catalog Number
ST-ADPT-30
Brand Name
SENSITHERM MULTI
Version/Model Number
ST-ADPT-30
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
K192210
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
0fb49c55-6836-4b48-b9d2-8c2ac2987bbc
Public Version Date
February 14, 2022
Public Version Number
1
DI Record Publish Date
February 04, 2022
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. | 42 |