510(k) K191710
K191710 is an FDA 510(k) premarket notification submitted by Inari Medical for the device "FlowTriever Retrieval/Aspiration System". The FDA issued a decision of Substantially Equivalent on Sep 5, 2019. The device falls under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration), a Class II device regulated under 21 CFR 870.5150. Inari Medical has 57 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 5, 2019
- Date Received
- Jun 26, 2019
- 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.