DeviceClearance

Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter— 510(k) K192302

Unknown

Covidien, LLC

FDA 510(k) clearance K192302 for Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter, Unknown on 2020-01-17. Applicant: Covidien, LLC. Device class: 2.

Clearance details

Applicant
Covidien, LLC
Product code
Code MPB
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 MPB

product code MPB
Death
18
Malfunction
1,042
Total
1,060

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 K192302

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 K192302.

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