The following data is part of a premarket notification filed by The Kendall Company with the FDA for Tandem-cath 10 Fr. Catheter System, Model Multiple Code Numbers.
| Device ID | K002902 |
| 510k Number | K002902 |
| Device Name: | TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | THE KENDALL COMPANY 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Frank J Fucile |
| Correspondent | Frank J Fucile THE KENDALL COMPANY 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-18 |
| Decision Date | 2001-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521009940 | K002902 | 000 |