510(k) K960372

SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM by Scanlan Intl., Inc. — Product Code HCH

K960372 is an FDA 510(k) premarket notification submitted by Scanlan Intl., Inc. for the device "SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM". The FDA issued a decision of Substantially Equivalent on April 26, 1996. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Scanlan Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1996
Date Received
January 26, 1996
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