510(k) K171268

Reverse 021 Micro Catheter, Reverse 027 Micro Catheter by Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular — Product Code DQY

K171268 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular for the device "Reverse 021 Micro Catheter, Reverse 027 Micro Catheter". The FDA issued a decision of Substantially Equivalent on May 31, 2017. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular has 31 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2017
Date Received
May 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type
510(k)