The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As Kendall with the FDA for Palindrome P Hemodialysis Catheter.
| Device ID | K092205 |
| 510k Number | K092205 |
| Device Name: | PALINDROME P HEMODIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Daniel Campion |
| Correspondent | Daniel Campion COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-22 |
| Decision Date | 2009-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521135581 | K092205 | 000 |
| 10884521135574 | K092205 | 000 |
| 10884521135567 | K092205 | 000 |
| 10884521135550 | K092205 | 000 |
| 10884521135543 | K092205 | 000 |
| 10884521135536 | K092205 | 000 |