510(k) K060625

NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR by Micro Therapeutics, Inc. — Product Code HCG

K060625 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. for the device "NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR". The FDA issued a decision of Substantially Equivalent on April 20, 2006. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Micro Therapeutics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2006
Date Received
March 9, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Neurovascular Embolization
Device Class
Class II
Regulation Number
882.5950
Review Panel
NE
Submission Type