510(k) K240384

SENDERO Microcatheter by Okami Medical, Inc. — Product Code DQY

K240384 is an FDA 510(k) premarket notification submitted by Okami Medical, Inc. for the device "SENDERO Microcatheter". The FDA issued a decision of Substantially Equivalent on March 8, 2024. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Okami Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2024
Date Received
February 8, 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