510(k) K251185
K251185 is an FDA 510(k) premarket notification submitted by Intervene for the device "Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)". The FDA issued a decision of Substantially Equivalent on October 22, 2025. The device falls under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration), a Class II device regulated under 21 CFR 870.5150. Intervene has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2025
- Date Received
- April 16, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Peripheral Mechanical Thrombectomy With Aspiration
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.