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510(k) K011056

ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD by Arrow Intl., Inc. — Product Code QEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2001
Date Received
April 6, 2001
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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