MODIFICATION TO VAXCEL DIALYSIS CATHETER— 510(k) K012948

Substantially Equivalent

Boston Scientific/Medi-Tech

FDA 510(k) clearance K012948 for MODIFICATION TO VAXCEL DIALYSIS CATHETER, Substantially Equivalent on 2001-10-03. Applicant: Boston Scientific/Medi-Tech.

Clearance details

Applicant: Boston Scientific/Medi-Tech
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2001-09-04
Decision date: 2001-10-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.