Duns Number:030096122
Device Description: The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to pr The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to provide a means of laparoscopic cholangiography. It comprises a translucent tubing ( 76 cm. length and 16 ga. ) that carries a 19 ga., 1.25 cm long needle at the end. The Kumar Catheter® is used to puncture the Hartmann's pouch of the gallbladder for biliary access and / or aspiration. Product is latex free.
Catalog Number
CC-019
Brand Name
Kumar Catheter®
Version/Model Number
CC019
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K973621,K973621
Product Code
GBZ
Product Code Name
Catheter, Cholangiography
Public Device Record Key
b243bd66-2330-4f16-ad1a-0f037f481d94
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 15, 2017
Package DI Number
B361CC0191
Quantity per Package
20
Contains DI Package
B361CC0190
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |