510(k) K112156 ยท JXG Shunt, Central Nervous System And Components
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
| Applicant | Medos International SARL, Raynham MA, US |
| Decision | Substantially Equivalent, Oct 17, 2011 |
| Received | Jul 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112156
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2014 | Codman & Shurtleff, Inc. Codman Certas - In Line Valve Only; Product Code: 82-8800
The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebros Terminated |
JXG | None listed |
| Aug 12, 2014 | Codman & Shurtleff, Inc. Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801
The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and Terminated |
JXG | None listed |
| Aug 12, 2014 | Codman & Shurtleff, Inc. Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802
The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pres Terminated |
JXG | None listed |
| Aug 12, 2014 | Codman & Shurtleff, Inc. Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8803
The Codman Certas Programmable valve is an implantable device that provides constant intraventri Terminated |
JXG | None listed |
| Aug 12, 2014 | Codman & Shurtleff, Inc. Codman Certas - In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804
The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and d Terminated |
JXG | None listed |
| Aug 12, 2014 | Codman & Shurtleff, Inc. Codman Certas - In Line Valve with SIPHONGUARD Device, Catheter and Accessories; Product Code: 82-8805
The Codman Certas Programmable valve is an implantable device that provides constant intraventri Terminated |
JXG | None listed |
| Aug 12, 2014 | Codman & Shurtleff, Inc. Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories; Product Code: 82-8806
The Codman Certas Programmable valve is an implantable device that provides constant intravent Terminated |
JXG | None listed |
| Aug 12, 2014 | Codman & Shurtleff, Inc. Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8807
The Codman Certas Programmable valve is an implantable device that provides c Terminated |
JXG | None listed |
| Apr 17, 2014 | Codman & Shurtleff, Inc. CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows:
82-8800 In Line Valve Only
82-8801 In Line Valve with Catheter and Accessories
82-8802 In Line Valve with Unitized Terminated |
JXG | None listed |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve Only
Product Code: 82-8800
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressur Terminated |
JXG | None listed |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve with Catheter and Accessories
Product Code: 82-8801
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device that provides constant Terminated |
JXG | None listed |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories
Product Code: 82-8803
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device that Terminated |
JXG | None listed |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device
Product Code: 82-8804
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device that provides constant i Terminated |
JXG | None listed |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories
Product Code: 82-8805
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device tha Terminated |
JXG | None listed |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories
Product Code: 82-8806
Product Usage:
The CODMAN CERTAS Programmable Valve is an implantable device Terminated |
JXG | None listed |
| Jan 29, 2014 | Codman & Shurtleff, Inc. Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories
Product Code: 82-8807
Product Usage:
The CODMAN CERTAS Programmable Valve is an i Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.