510(k) K253070
K253070 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)". The FDA issued a decision of Substantially Equivalent on November 20, 2025. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Medline Industries, LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2025
- Date Received
- September 23, 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