510(k) K133681

CRUX SNARE FILTER RETRIEVAL SET by Volcano Corporation — Product Code MMX

K133681 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "CRUX SNARE FILTER RETRIEVAL SET". The FDA issued a decision of Substantially Equivalent on January 30, 2014. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Volcano Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2014
Date Received
December 2, 2013
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