Duns Number:076769355
Device Description: The Guiding Catheter is a sterile device inserted through a compatible flexible endoscope The Guiding Catheter is a sterile device inserted through a compatible flexible endoscope to aid in the initial placement of a stent, typically into a pancreatic or biliary duct in order to maintain patency. It is made of polytetrafluoroethylene (PTFE) with a radiopaque marker on the distal end. This is a single-use device.
Catalog Number
6130
Brand Name
Hobbs Guiding Catheter
Version/Model Number
6130
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
K834351
Product Code
FGE
Product Code Name
Catheter, Biliary, Diagnostic
Public Device Record Key
2071b254-aa2a-4a48-ba7e-833c56eee7d4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 196 |