510(k) K073139

SMALL LUMEN PERITONEAL CATHETER by Medtronic Neurosurgery — Product Code JXG

K073139 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "SMALL LUMEN PERITONEAL CATHETER". The FDA issued a decision of Substantially Equivalent on January 30, 2008. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2008
Date Received
November 7, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type