The following data is part of a premarket notification filed by The Kendall Company with the FDA for Mahurkar Oplus Catheter, Model 13.5 Fr.
| Device ID | K030209 |
| 510k Number | K030209 |
| Device Name: | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR |
| Classification | Catheter, Hemodialysis, 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 | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521519558 | K030209 | 000 |
| 10884521058392 | K030209 | 000 |
| 10884521832848 | K030209 | 000 |
| 10884521832855 | K030209 | 000 |
| 10884521832862 | K030209 | 000 |
| 20884521006581 | K030209 | 000 |
| 20884521058375 | K030209 | 000 |
| 10884521519534 | K030209 | 000 |
| 20884521058399 | K030209 | 000 |
| 10884521058378 | K030209 | 000 |