The following data is part of a premarket notification filed by The Kendall Company with the FDA for Mahurkar Triple Lumen Catheter, 12 Fr.
| Device ID | K020089 |
| 510k Number | K020089 |
| Device Name: | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR |
| Classification | Catheter, Hemodialysis, Triple Lumen, Non-implanted |
| Applicant | THE KENDALL COMPANY 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Regina Yeh |
| Correspondent | Regina Yeh THE KENDALL COMPANY 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | NIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-10 |
| Decision Date | 2002-04-10 |
| Summary: | summary |