ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER— 510(k) K102043

Name: FDA 510(k) clearance K102043
Creator: U.S. Food and Drug Administration
Published: 2010-11-18

Substantially Equivalent

Rex Medical

FDA 510(k) clearance K102043 for ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER, Substantially Equivalent on 2010-11-18. Applicant: Rex Medical. Device class: 2.

Clearance details

Applicant: Rex Medical
Product code: Code MSD
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2010-07-20
Decision date: 2010-11-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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K091029 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)2010-02-18
K081410 — OPTION VENA CAVA FILTER2009-06-04
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Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

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 →

Recalls naming K102043

K-number listed on FDA's recall record

Z-2696-2014 — UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.Class II·Terminated·Argon Medical Devices, Inc·20140605
Z-2697-2014 — UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.Class II·Terminated·Argon Medical Devices, Inc·20140605
Z-2698-2014 — UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.Class II·Terminated·Argon Medical Devices, Inc·20140605

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102043.

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