510(k) K140151
K140151 is an FDA 510(k) premarket notification submitted by Btg International, Inc. for the device "EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT". The FDA issued a decision of Substantially Equivalent on May 21, 2014. The device falls under product code QEY (Mechanical Thrombolysis Catheter), a Class II device regulated under 21 CFR 870.5150. Btg International, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2014
- Date Received
- January 22, 2014
- Clearance Type
- Traditional
- 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.