510(k) K260559
K260559 is an FDA 510(k) premarket notification submitted by IMDS Operation B.V. for the device "NHanceIT". The FDA issued a decision of Substantially Equivalent on August 14, 2026. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2026
- Date Received
- February 19, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type