510(k) K170987

Captus Vascular Retrieval System by Avantec Vascular Corporation — Product Code MMX

K170987 is an FDA 510(k) premarket notification submitted by Avantec Vascular Corporation for the device "Captus Vascular Retrieval System". The FDA issued a decision of Substantially Equivalent on August 28, 2017. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Avantec Vascular Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2017
Date Received
April 3, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Percutaneous Retrieval
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type