510(k) K252772

Arc Adjustable Radial Cuff Compression Device by Tz Medical, Inc. — Product Code DXC

K252772 is an FDA 510(k) premarket notification submitted by Tz Medical, Inc. for the device "Arc Adjustable Radial Cuff Compression Device". The FDA issued a decision of Substantially Equivalent on May 22, 2026. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Tz Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2026
Date Received
September 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type