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Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit

FDA 510(k) clearance K153347 · decided 2016-08-19

Clearance details

K-number
K153347
Device name
Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit
Applicant
Codman & Shurtleff, Inc.
Decision
Substantially Equivalent
Date received
2015-11-20
Decision date
2016-08-19
Days to decision
273 days
Clearance type
Traditional
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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