510(k) K171493
K171493 is an FDA 510(k) premarket notification submitted by Capture Vascular, Inc. for the device "MegaVac Mechanical Thrombectomy System". The FDA issued a decision of Substantially Equivalent on August 10, 2017. The device falls under product code QEX (Coronary Mechanical Thrombectomy With Aspiration), a Class II device regulated under 21 CFR 870.5150.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2017
- Date Received
- May 22, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coronary 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 coronary vasculature through aspiration.