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…
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.
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Kumar Catheter® | Listed by | Nashville Surgical Instruments, United States |
| FDA product code | GBZ |
| Device type | Catheter, Cholangiography |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K973621 |
| Record published | 2017-08-15 |
| Record revised | 2024-05-03 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity 30 to 70 % RH; Storage environment temperature 45 to 85 °F |
| Packaging | Box of 20 |
| UDI direct marking | Exempt |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.