510(k) K250133
K250133 is an FDA 510(k) premarket notification submitted by Nuvascular, Inc. for the device "HARBOR Occlusion Device". The FDA issued a decision of Substantially Equivalent on July 9, 2025. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Nuvascular, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2025
- Date Received
- January 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Vascular, For Promoting Embolization
- Device Class
- Class II
- Regulation Number
- 870.3300
- Review Panel
- CV
- Submission Type