SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL

Shunt, Central Nervous System And Components

MEDICAL DESIGNS, LLC

The following data is part of a premarket notification filed by Medical Designs, Llc with the FDA for Subdural Evacuating Port System Cranial Access Kit (seps-ca), (seps-cal), (seps-cand),models 11-0401 Ca, 11-0401-cal.

Pre-market Notification Details

• Device ID: K042359
• 510k Number: K042359
• Device Name: SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
• Classification: Shunt, Central Nervous System And Components
• Applicant: MEDICAL DESIGNS, LLC 1210 W. 18TH ST. NORTH CENTER, SUITE 104 Sioux Falls, SD 57104
• Contact: Paul John Axt
• Correspondent: Paul John Axt; MEDICAL DESIGNS, LLC 1210 W. 18TH ST. NORTH CENTER, SUITE 104 Sioux Falls, SD 57104
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2004-08-31
• Decision Date: 2004-11-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994334749	K042359	000
00613994334732	K042359	000