Atlas FDA

AESCULAP- MEITHKE SHUNT SYSTEM

FDA 510(k) clearance K110206 · decided 2011-10-27

Clearance details

K-number
K110206
Device name
AESCULAP- MEITHKE SHUNT SYSTEM
Applicant
Aesculap, Inc.
Decision
Substantially Equivalent
Date received
2011-01-25
Decision date
2011-10-27
Days to decision
275 days
Clearance type
Traditional
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Center Valley, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shun recall (Z-0814-2015)Aesculap, Inc.2014-12-16
Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and F recall (Z-0805-2013)Aesculap, Inc.2013-02-12