DeviceClearance

DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT— 510(k) K101843

Unknown

AngioDynamics, Inc.

FDA 510(k) clearance K101843 for DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT, Unknown on 2010-10-20. Applicant: AngioDynamics, Inc.. Device class: 2.

Clearance details

Applicant
AngioDynamics, Inc.
Product code
Code MSD
Device class
Class 2
Regulation
21 CFR 876.5540
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Latham, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MSD

product code MSD
Death
67
Injury
545
Malfunction
3,661
Total
4,273

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

Recalls naming K101843

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101843.

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