CODMAN MICROSENSOR VENTRICULAR CATHETER KIT

Device, Monitoring, Intracranial Pressure

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Codman Microsensor Ventricular Catheter Kit.

Pre-market Notification Details

• Device ID: K991222
• 510k Number: K991222
• Device Name: CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
• Classification: Device, Monitoring, Intracranial Pressure
• Applicant: JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Contact: James M Flaherty
• Correspondent: James M Flaherty; JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767
• Product Code: GWM
• CFR Regulation Number: 882.1620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-12
• Decision Date: 1999-07-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20886704042492	K991222	000
20886704042331	K991222	000
10886704045120	K991222	000
10381780520566	K991222	000
10381780520436	K991222	000