510(k) K102605 ยท NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
| Applicant | Covidien, LLC, Formerly Registered AS Tyco Healthca, Mansfield MA, US |
| Decision | Unknown, Dec 22, 2010 |
| Received | Sep 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102605
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray
REF:8888101001HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray
REF: 8888101002HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray
REF: 8888101003HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray
REF: 8888101004HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray
REF: 8888102003HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray
REF: 8888102004HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray
REF: 8888103001HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray
REF: 8888103002HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray
REF: 8888103004HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray
REF: 8888104003HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray
REF: 8888104004HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit
REF: 8888340629 Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit
REF: 8888340629HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit
REF: 8888340637 Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit
REF: 8888340637HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions
REF: 8888345512HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions
REF: 8888345520HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit"
REF: 8888345603 Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit
REF: 8888345603HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit"
REF: 8888345611 Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit
REF: 8888345611HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit"
REF: 8888345629 Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit
REF: 8888345629HP Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit
REF: 8888345637 Open, Classified |
NIE | None listed |
| Aug 11, 2023 | Covidien LP MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit
REF: 8888345637HP 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.