510(k) K030209 ยท MPB Catheter, Hemodialysis, Non-Implanted
MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
| Applicant | The Kendall Company, Mansfield MA, US |
| Decision | Substantially Equivalent, May 13, 2003 |
| Received | Jan 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2023 | Covidien LP MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only:
13.5cm, Straight Extensions, Kit - Model No. 8888135131;
13.5 cm, Curved Extensions, Kit - Model No. 8888 Open, Classified |
NIE | None listed |
| Apr 29, 2019 | COVIDIEN LLC MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009
8813793013
8813794005
8813794009
8813816005
8813816009
8813817005
8813817009
8815668007
8815668011
8815668021
8815668027
8 Terminated |
NIE | None listed |
| Dec 17, 2003 | Kendall Healthcare Products Co Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm
For hemodialysis, apheresis, and infusion.
Reference: 8888-135192 Terminated |
MPB | None listed |
| Dec 17, 2003 | Kendall Healthcare Products Co Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm
For hemodialysis, apheresis, and infusion
Reference: 8888-135195 Terminated |
MPB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.