K040492 is an FDA 510(k) clearance for the VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER. This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 16, 2004, 19 days after receiving the submission on February 26, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K040492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2004 |
| Decision Date | March 16, 2004 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSD — Catheter, Hemodialysis, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |