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Panels › Neurology › Product code PCB · Class 2

External Cerebrospinal Fluid (Csf) Diversion

Regulation 882.5560

0510(k)s in 12 months (2 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
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Top companies in PCB

Company510(k)sRecalls
Medtronic Neurosurgery25
DateFirm and productCodeLinked 510(k)
Feb 27, 2024Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracr
Open, Classified
PCBNone listed
Feb 27, 2024Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce in
Open, Classified
PCBNone listed
Feb 27, 2024Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce in
Open, Classified
PCBNone listed
Feb 27, 2024Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure a
Open, Classified
PCBNone listed
Feb 27, 2024Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure an
Open, Classified
PCBNone listed

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