510(k) K991222

CODMAN MICROSENSOR VENTRICULAR CATHETER KIT by Johnson & Johnson Professionals, Inc. — Product Code GWM

K991222 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "CODMAN MICROSENSOR VENTRICULAR CATHETER KIT". The FDA issued a decision of Substantially Equivalent on July 9, 1999. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1999
Date Received
April 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type