DXC · Class II · 21 CFR 870.4450

FDA Product Code DXC: Clamp, Vascular

Leading manufacturers include Ningbo Dizegens Medical Science Co.,Ltd, Arc Trauma, LLC and Medline Industries, LP.

202
Total
202
Cleared
132d
Avg days
1976
Since
Declining activity - 3 submissions in the last 2 years vs 6 in the prior period
Review times increasing: avg 189d recently vs 131d historically

FDA 510(k) Cleared Clamp, Vascular Devices (Product Code DXC)

202 devices
1–24 of 202

About Product Code DXC - Regulatory Context

510(k) Submission Activity

202 total 510(k) submissions under product code DXC since 1976, with 202 receiving FDA clearance (average review time: 132 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 6 in the prior period.

FDA Review Time

Recent submissions under DXC have taken an average of 189 days to reach a decision - up from 131 days historically. Manufacturers should account for longer review timelines in current project planning.

DXC devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →