510(k) K223929
K223929 is an FDA 510(k) premarket notification submitted by Innova Vascular, Inc. for the device "Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System)". The FDA issued a decision of Substantially Equivalent on Jun 1, 2023. 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
- Jun 1, 2023
- Date Received
- Dec 30, 2022
- 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.