The following data is part of a premarket notification filed by Covidien with the FDA for Palindrome Rt Chronic Catheter.
| Device ID | K111817 |
| 510k Number | K111817 |
| Device Name: | PALINDROME RT CHRONIC CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Wing Ng |
| Correspondent | Wing Ng COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-27 |
| Decision Date | 2011-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521135529 | K111817 | 000 |
| 10884521135505 | K111817 | 000 |
| 10884521135482 | K111817 | 000 |
| 10884521135475 | K111817 | 000 |
| 10884521135512 | K111817 | 000 |
| 10884521135499 | K111817 | 000 |