The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Vaxcel Plus Chronic Dialysis Catheter.
| Device ID | K032712 |
| 510k Number | K032712 |
| Device Name: | VAXCEL PLUS CHRONIC DIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | Nicholas Condakes |
| Correspondent | Nicholas Condakes BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-02 |
| Decision Date | 2003-10-02 |
| Summary: | summary |