510(k) K041705
K041705 is an FDA 510(k) premarket notification submitted by Omnisonics Medical Technologies for the device "RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2". The FDA issued a decision of Substantially Equivalent on September 1, 2004. The device falls under product code QEY (Mechanical Thrombolysis Catheter), a Class II device regulated under 21 CFR 870.5150. Omnisonics Medical Technologies has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2004
- Date Received
- June 23, 2004
- 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.