Atlas FDA

CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM

FDA 510(k) clearance K113526 · decided 2012-02-16

Clearance details

K-number
K113526
Device name
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
Applicant
Medos International SARL
Decision
Substantially Equivalent
Date received
2011-11-30
Decision date
2012-02-16
Days to decision
78 days
Clearance type
Special
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Raynham, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable v recall (Z-2184-2014)Codman & Shurtleff, Inc.2014-08-12
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Cod recall (Z-2185-2014)Codman & Shurtleff, Inc.2014-08-12
Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-880 recall (Z-2186-2014)Codman & Shurtleff, Inc.2014-08-12
Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product Co recall (Z-2187-2014)Codman & Shurtleff, Inc.2014-08-12
Codman Certas - In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804 The Codm recall (Z-2188-2014)Codman & Shurtleff, Inc.2014-08-12
Codman Certas - In Line Valve with SIPHONGUARD Device, Catheter and Accessories; Product C recall (Z-2189-2014)Codman & Shurtleff, Inc.2014-08-12
Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories; Product recall (Z-2190-2014)Codman & Shurtleff, Inc.2014-08-12
Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Acc recall (Z-2191-2014)Codman & Shurtleff, Inc.2014-08-12
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-880 recall (Z-1468-2014)Codman & Shurtleff, Inc.2014-04-17
Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: T recall (Z-0858-2014)Codman & Shurtleff, Inc.2014-01-29
Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: recall (Z-0859-2014)Codman & Shurtleff, Inc.2014-01-29
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Access recall (Z-0860-2014)Codman & Shurtleff, Inc.2014-01-29
Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: recall (Z-0861-2014)Codman & Shurtleff, Inc.2014-01-29
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Acces recall (Z-0862-2014)Codman & Shurtleff, Inc.2014-01-29
Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Acc recall (Z-0863-2014)Codman & Shurtleff, Inc.2014-01-29
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal recall (Z-0864-2014)Codman & Shurtleff, Inc.2014-01-29