The following data is part of a premarket notification filed by Covidien Llc, Formerly Registered As Tyco Healthca with the FDA for Mahurkar Triple Lumen Dialysis Catheter.
| Device ID | K102605 |
| 510k Number | K102605 |
| Device Name: | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Triple Lumen, Non-implanted |
| Applicant | COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Daniel Campion |
| Correspondent | Daniel Campion COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | NIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-10 |
| Decision Date | 2010-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40884521128010 | K102605 | 000 |
| 20884521128139 | K102605 | 000 |
| 20884521128122 | K102605 | 000 |
| 20884521128115 | K102605 | 000 |
| 20884521128092 | K102605 | 000 |
| 20884521128085 | K102605 | 000 |
| 20884521128078 | K102605 | 000 |
| 20884521128160 | K102605 | 000 |
| 20884521128108 | K102605 | 000 |
| 30884521127993 | K102605 | 000 |
| 20884521128146 | K102605 | 000 |
| 20884521128184 | K102605 | 000 |
| 30884521128006 | K102605 | 000 |
| 30884521127979 | K102605 | 000 |
| 20884521128061 | K102605 | 000 |
| 20884521128054 | K102605 | 000 |
| 20884521128047 | K102605 | 000 |
| 20884521128030 | K102605 | 000 |
| 20884521128023 | K102605 | 000 |
| 10884521128002 | K102605 | 000 |
| 10884521127999 | K102605 | 000 |
| 10884521127890 | K102605 | 000 |