The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter.
| Device ID | K192302 |
| 510k Number | K192302 |
| Device Name: | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | Covidien, Llc 15 Hampshire Street Mansfield, MA 02048 |
| Contact | Carol S Ming |
| Correspondent | Carol S Ming Covidien, Llc 15 Hampshire Street Mansfield, MA 02048 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-08-23 |
| Decision Date | 2020-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521005314 | K192302 | 000 |
| 20884521005348 | K192302 | 000 |
| 20884521005300 | K192302 | 000 |
| 20884521005171 | K192302 | 000 |
| 20884521005157 | K192302 | 000 |