MIETHKE SHUNT SYSTEM— 510(k) K020728

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K020728 for MIETHKE SHUNT SYSTEM, Substantially Equivalent on 2002-04-05. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code HCA
Device class: Class 2
Regulation: 21 CFR 882.4100
Advisory panel: Neurology
Date received: 2002-03-06
Decision date: 2002-04-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K020728

K-number listed on FDA's recall record

Z-0805-2013 — Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.Class II·Terminated·Aesculap, Inc.·20120604

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020728.

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