DeviceClearance

Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions— 510(k) K143102

Unknown

Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

FDA 510(k) clearance K143102 for Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions, Unknown on 2015-07-24. Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.). Device class: 2.

Clearance details

Applicant
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
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
Reading, PA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

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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 K143102

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 K143102.

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