Data / Medical devices / Germany / christoph miethke gmbh & co.kg
christoph miethke gmbh & co.kg: FDA-registered device maker in potsdam Brandenburg, Germany, 12 510(k) clearances
christoph miethke gmbh & co.kg is registered with the FDA (registration 3004721439) in potsdam Brandenburg, Germany. It lists 3 device types. The FDA files 12 510(k) clearances under its listings, the newest dated May 8, 2020. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004721439
- Address
- ulanenweg 2 potsdam, potsdam Brandenburg, Germany, 14469
- Owner or operator
- christoph miethke gmbh & co.kg (10023285)
- Roles
- Manufacturer
- First device listed
- November 15, 2007
- Registered through
- 2026
- Brand names listed
- Aesculap Miethke Ventricular Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Ventricular | HCA | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Shunt System Implantation | GYK | 1 | Manufacturer | accessdata.fda.gov |
| Shunt, Central Nervous System And Components | JXG | 2 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 8, 2020 | K200950 | Ventricular Catheter | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 5, 2019 | K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 Valves | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| February 27, 2017 | K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| April 2, 2015 | K141687 | AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| May 24, 2012 | K120559 | AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| October 27, 2011 | K110206 | AESCULAP- MEITHKE SHUNT SYSTEM | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| November 9, 2010 | K103003 | AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| January 17, 2007 | K062009 | AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| June 4, 2003 | K031303 | AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 20, 2003 | K030698 | AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| April 5, 2002 | K020728 | MIETHKE SHUNT SYSTEM | HCA | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 1, 2002 | K011030 | AESCULAP -MIETHKE SHUNT SYSTEM | JXG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Shunt, Central Nervous System And Components
- All makers of Catheter, Ventricular
- All makers of Instrument, Shunt System Implantation
Updated May 8, 2020. 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.