510(k) K241177

React 71 Catheter by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular — Product Code DQY

K241177 is an FDA 510(k) premarket notification submitted by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular for the device "React 71 Catheter". The FDA issued a decision of Substantially Equivalent on May 28, 2024. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2024
Date Received
April 29, 2024
Clearance Type
Special
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