510(k) K182835
K182835 is an FDA 510(k) premarket notification submitted by 880 Medical, LLC for the device "WOLF Thrombectomy Device". The FDA issued a decision of Substantially Equivalent on Mar 27, 2019. The device falls under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration), a Class II device regulated under 21 CFR 870.5150.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 27, 2019
- Date Received
- Oct 9, 2018
- 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
- 510(k)
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.