CereLink ICP Monitor, CereLink ICP Extension Cable

Device, Monitoring, Intracranial Pressure

Integra LifeSciences Corp.

The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Cerelink Icp Monitor, Cerelink Icp Extension Cable.

Pre-market Notification Details

• Device ID: K183406
• 510k Number: K183406
• Device Name: CereLink ICP Monitor, CereLink ICP Extension Cable
• Classification: Device, Monitoring, Intracranial Pressure
• Applicant: Integra LifeSciences Corp. 11 Cabot Blvd Mansfield, MA 02048
• Contact: Megan Palumbo
• Correspondent: Megan Palumbo; Integra LifeSciences Corp. 11 Cabot Blvd Mansfield, MA 02048
• Product Code: GWM
• CFR Regulation Number: 882.1620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-10
• Decision Date: 2019-01-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10381780529033	K183406	000
10381780520665	K183406	000
10886704081104	K183406	000
10886704081098	K183406	000
10886704075622	K183406	000
10886704075608	K183406	000
10381780533788	K183406	000
10381780533771	K183406	000
10381780533764	K183406	000