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510(k) K080901

LBI EMBOLECTOMY SYSTEM by Lumen Biomedical, Inc. — Product Code QEW

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.

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