510(k) K024349

AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER by Aesculap, Inc. — Product Code HCH

K024349 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER". The FDA issued a decision of Substantially Equivalent on March 24, 2003. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2003
Date Received
December 30, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Aneurysm
Device Class
Class II
Regulation Number
882.5200
Review Panel
NE
Submission Type