510(k) K200648
K200648 is an FDA 510(k) premarket notification submitted by Ekos Corporation for the device "EKOS PE Endovascular Device with Control System 4.0 (CS4.0)". The FDA issued a decision of Substantially Equivalent on August 17, 2020. The device falls under product code QEY (Mechanical Thrombolysis Catheter), a Class II device regulated under 21 CFR 870.5150. Ekos Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2020
- Date Received
- March 12, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mechanical Thrombolysis Catheter
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.