510(k) K193071
K193071 is an FDA 510(k) premarket notification submitted by Thrombolex, Inc. for the device "Bashir Plus Endovascular Catheter". The FDA issued a decision of Substantially Equivalent on December 17, 2019. The device falls under product code QEY (Mechanical Thrombolysis Catheter), a Class II device regulated under 21 CFR 870.5150. Thrombolex, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2019
- Date Received
- November 4, 2019
- 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.