510(k) K260677
K260677 is an FDA 510(k) premarket notification submitted by Vcd Medical S.R.L. for the device "Vessel Closure Device (VCD177213P)". The FDA issued a decision of Substantially Equivalent on September 17, 2026. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2026
- Date Received
- March 2, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type