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CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit

FDA 510(k) clearance K173192 · decided 2017-11-08

Clearance details

K-number
K173192
Device name
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
Applicant
Codman & Shurtleff, Inc.
Decision
Substantially Equivalent
Date received
2017-10-02
Decision date
2017-11-08
Days to decision
37 days
Clearance type
Special
Product code
GWM
Device class
2
Regulation number
882.1620
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

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