Atlas FDA

BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM

FDA 510(k) clearance K984053 · decided 1999-02-04

Clearance details

K-number
K984053
Device name
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
Applicant
Medtronic PS Medical
Decision
Substantially Equivalent
Date received
1998-11-06
Decision date
1999-02-04
Days to decision
90 days
Clearance type
Traditional
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Goleta, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection site recall (Z-2412-2023)Medtronic Neurosurgery2023-08-17
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog recall (Z-1920-2014)Medtronic Neurosurgery2014-06-27
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog recall (Z-1921-2014)Medtronic Neurosurgery2014-06-27
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventric recall (Z-1922-2014)Medtronic Neurosurgery2014-06-27
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventric recall (Z-1923-2014)Medtronic Neurosurgery2014-06-27
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar recall (Z-1924-2014)Medtronic Neurosurgery2014-06-27