HCH · Class II · 21 CFR 882.5200

FDA Product Code HCH: Clip, Aneurysm

Leading manufacturers include Mizuho America, Inc..

36
Total
36
Cleared
187d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Clip, Aneurysm Devices (Product Code HCH)

36 devices
1–24 of 36

About Product Code HCH - Regulatory Context

510(k) Submission Activity

36 total 510(k) submissions under product code HCH since 1976, with 36 receiving FDA clearance (average review time: 187 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

HCH devices are reviewed by the Neurology panel. Browse all Neurology devices →