510(k) K251277

CoraForce Microcatheter, CoraFlex Microcatheter by Reflow Medical, Inc. — Product Code DQY

K251277 is an FDA 510(k) premarket notification submitted by Reflow Medical, Inc. for the device "CoraForce Microcatheter, CoraFlex Microcatheter". The FDA issued a decision of Substantially Equivalent on August 22, 2025. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Reflow Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2025
Date Received
April 24, 2025
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