510(k) K233268

Impress Angiographic Catheter by Merit Medical Systems, Inc. — Product Code DQO

K233268 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Impress Angiographic Catheter". The FDA issued a decision of Substantially Equivalent on May 22, 2024. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2024
Date Received
September 29, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type