510(k) K231653
K231653 is an FDA 510(k) premarket notification submitted by Thrombolex, Inc. for the device "BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter". The FDA issued a decision of Substantially Equivalent on July 3, 2023. 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
- July 3, 2023
- Date Received
- June 6, 2023
- 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.