510(k) K032198

AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP by Aesculap, Inc. — Product Code HCH

K032198 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP". The FDA issued a decision of Substantially Equivalent on August 20, 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
August 20, 2003
Date Received
July 18, 2003
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