STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836

Shunt, Central Nervous System And Components

MEDTRONIC NEUROSURGERY

The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Strata Burr Hole Valve, Model 42836 And Strata Burr Hole Shunt Assembly, Model 46836.

Pre-market Notification Details

• Device ID: K083076
• 510k Number: K083076
• Device Name: STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
• Classification: Shunt, Central Nervous System And Components
• Applicant: MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117
• Contact: Jeffrey Henderson
• Correspondent: Jeffrey Henderson; MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-10-16
• Decision Date: 2008-11-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994380111	K083076	000
00613994380098	K083076	000
00643169975941	K083076	000
00643169975811	K083076	000
00643169840980	K083076	000
00643169840959	K083076	000
00763000031237	K083076	000
00763000031398	K083076	000