510(k) K984022— PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT

Substantially Equivalent

Arrow Intl., Inc.

Clearance details

Applicant: Arrow Intl., Inc.
Product code: Code MPB
Advisory panel: Gastroenterology, Urology
Date received: 1998-11-12
Decision date: 1999-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

Adverse events under product code MPB

product code MPB

Death: 18
Malfunction: 1,042
Total: 1,060

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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