DeviceClearance

MAHURKAR TRIPLE LUMEN CATHETER, 12 FR— 510(k) K020089

Substantially Equivalent

The Kendall Company

FDA 510(k) clearance K020089 for MAHURKAR TRIPLE LUMEN CATHETER, 12 FR, Substantially Equivalent on 2002-04-10. Applicant: The Kendall Company. Device class: 2.

Clearance details

Applicant
The Kendall Company
Product code
Code NIE
Device class
Class 2
Regulation
21 CFR 876.5540
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
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 K020089

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 K020089.

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