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Data / Medical devices / Germany / Christoph Miethke GMBH & Co.kg

Christoph Miethke GMBH & Co.kg: FDA-registered device maker in potsdam Brandenburg, Germany, 5 510(k) clearances

Christoph Miethke GMBH & Co.kg is registered with the FDA (registration 3015462837) in potsdam Brandenburg, Germany. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 16, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3015462837
Address
Fritz-von-der-Lancken-Strasse 10 potsdam, potsdam Brandenburg, Germany, 14469
Owner or operator
christoph miethke gmbh & co.kg (10023285)
Roles
Complaint file establishment, Manufacturer
First device listed
November 15, 2007
Registered through
2026
Brand names listed
M.Blue Adjustable Shunt System, XABO Catheter Set, XABO Peritoneal Catheter, XABO Ventricular Catheter

Devices it lists

DeviceProduct codeClassRoleSource
Instrument, Shunt System ImplantationGYK1Manufactureraccessdata.fda.gov
Shunt, Central Nervous System And ComponentsJXG2Complaint file establishment, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 16, 2024K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXGSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
November 21, 2019K192266M. Blue Adjustable Shunt SystemJXGSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
July 5, 2019K190174Miethke Shunt System GAV 2.0 and SA 2.0 ValvesJXGSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
January 17, 2007K062009AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451TJXGSubstantially EquivalentAesculap, Inc.accessdata.fda.gov
March 1, 2002K011030AESCULAP -MIETHKE SHUNT SYSTEMJXGSubstantially EquivalentAesculap, Inc.accessdata.fda.gov

Compare with other makers

Updated December 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.