The following data is part of a premarket notification filed by Kendall with the FDA for Tandem-cath Hemodialysis Catheter, Model 10 Fr.
| Device ID | K041006 |
| 510k Number | K041006 |
| Device Name: | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | James Welsh |
| Correspondent | James Welsh KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-19 |
| Decision Date | 2004-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521009971 | K041006 | 000 |
| 20884521009957 | K041006 | 000 |
| 10884521009967 | K041006 | 000 |