510(k) K152560

Bard Snare Retrieval Kit by Neometrics, Inc. — Product Code MMX

K152560 is an FDA 510(k) premarket notification submitted by Neometrics, Inc. for the device "Bard Snare Retrieval Kit". The FDA issued a decision of Substantially Equivalent on October 23, 2015. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Neometrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2015
Date Received
September 9, 2015
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