510(k) K080901
K080901 is an FDA 510(k) premarket notification submitted by Lumen Biomedical, Inc. for the device "LBI EMBOLECTOMY SYSTEM". The FDA issued a decision of SESU on October 2, 2008. The device falls under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration), a Class II device regulated under 21 CFR 870.5150. Lumen Biomedical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- October 2, 2008
- Date Received
- March 31, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Peripheral Mechanical Thrombectomy With Aspiration
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.