510(k) K212977

SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands by Cordis Corporation — Product Code DQO

K212977 is an FDA 510(k) premarket notification submitted by Cordis Corporation for the device "SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands". The FDA issued a decision of Substantially Equivalent on February 17, 2022. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Cordis Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2022
Date Received
September 17, 2021
Clearance Type
Traditional
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