SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER

Shunt, Central Nervous System And Components

ELEKTA IMPLANTS, SA

The following data is part of a premarket notification filed by Elekta Implants, Sa with the FDA for Subdural Drainage Catheter Kit, Subdural Catheter.

Pre-market Notification Details

• Device ID: K974726
• 510k Number: K974726
• Device Name: SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
• Classification: Shunt, Central Nervous System And Components
• Applicant: ELEKTA IMPLANTS, SA 6011 CELLINI ST. Coral Gables, FL 33146
• Contact: Barbra Ramseyer
• Correspondent: Barbra Ramseyer; ELEKTA IMPLANTS, SA 6011 CELLINI ST. Coral Gables, FL 33146
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-12-18
• Decision Date: 1998-03-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10381780034278	K974726	000
10381780034261	K974726	000