The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Vaxcel Plus Chronic Dialysis Catheter Tunneler.
| Device ID | K040492 |
| 510k Number | K040492 |
| Device Name: | VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Contact | Nicholas Condakes |
| Correspondent | Nicholas Condakes BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-26 |
| Decision Date | 2004-03-16 |
| Summary: | summary |