DeviceClearance

MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER— 510(k) K102605

Unknown

Covidien, LLC, Formerly Registered AS Tyco Healthca

FDA 510(k) clearance K102605 for MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER, Unknown on 2010-12-22. Applicant: Covidien, LLC, Formerly Registered AS Tyco Healthca. Device class: 2.

Clearance details

Applicant
Covidien, LLC, Formerly Registered AS Tyco Healthca
Product code
Code NIE
Device class
Class 2
Regulation
21 CFR 876.5540
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Mansfield, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NIE

product code NIE
Death
9
Other
1
Total
10

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 K102605

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 K102605.

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