Duns Number:079776997
Device Description: The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an inte The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer,a vessel dilator and guidewire. Used in conjunction with the Endophys Blood Pressure Monitor it is used to continuously monitor patient blood pressure during procedure requiring vascular access.
Catalog Number
-
Brand Name
Endophys Pressure Sensing Sheath Kit-6F
Version/Model Number
PSS-20-0612200-SCN
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
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
K141275
Product Code
DXO
Product Code Name
Transducer, Pressure, Catheter Tip
Public Device Record Key
53d663a6-4be2-49eb-8491-de644fb82b8d
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
April 10, 2017
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 |