510(k) K002871

MODIFICATION TO YASARGIL ANEURYSM CLIPS by Aesculap, Inc. — Product Code HCH

K002871 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "MODIFICATION TO YASARGIL ANEURYSM CLIPS". The FDA issued a decision of Substantially Equivalent on October 13, 2000. 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
October 13, 2000
Date Received
September 14, 2000
Clearance Type
Special
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