ClearanceBrief
510(k) K984053 ยท JXG Shunt, Central Nervous System And Components

BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM

ApplicantMedtronic PS Medical, Goleta CA, US
DecisionSubstantially Equivalent, Feb 4, 1999
ReceivedNov 6, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K984053

DateFirm and productCodeLinked 510(k)
Aug 17, 2023Medtronic Neurosurgery
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Open, Classified		 JXGNone listed
Jun 27, 2014Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of simil
Terminated		 JXGNone listed
Jun 27, 2014Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of simil
Terminated		 JXGNone listed
Jun 27, 2014Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and
Terminated		 JXGNone listed
Jun 27, 2014Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and
Terminated		 JXGNone listed
Jun 27, 2014Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and othe
Terminated		 JXGNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.