The following data is part of a premarket notification filed by Covidien with the FDA for Palindrome H, Si, Hsi Chronic Catheter.
| Device ID | K112477 |
| 510k Number | K112477 |
| Device Name: | PALINDROME H, SI, HSI CHRONIC CATHETER |
| Classification | Catheter, Hemodialysis, Implanted, Coated |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Wing Ng |
| Correspondent | Wing Ng COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | NYU |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-29 |
| Decision Date | 2011-09-28 |
| Summary: | summary |