510(k) K192302 ยท MPB Catheter, Hemodialysis, Non-Implanted
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
| Applicant | Covidien, LLC, Mansfield MA, US |
| Decision | Unknown, Jan 17, 2020 |
| Received | Aug 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192302
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2025 | Mozarc Medical US LLC MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm; Open, Classified |
NIE | None listed |
| Nov 4, 2025 | Mozarc Medical US LLC MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm; Open, Classified |
NIE | None listed |
| Nov 4, 2025 | Mozarc Medical US LLC MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; Open, Classified |
NIE | None listed |
| Nov 4, 2025 | Mozarc Medical US LLC MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; Open, Classified |
NIE | None listed |
| Nov 4, 2025 | Mozarc Medical US LLC MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm; Open, Classified |
NIE | None listed |
| Nov 4, 2025 | Mozarc Medical US LLC MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm; Open, Classified |
NIE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.