510(k) K253526
K253526 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "NAMIC Dilator and Sheath". The FDA issued a decision of Substantially Equivalent on July 29, 2026. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Medline Industries, LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2026
- Date Received
- November 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type