510(k) K243193

Cross Wise™ Multi-Use RF Adapter Cable by Circa Scientific, Inc. — Product Code DXF

K243193 is an FDA 510(k) premarket notification submitted by Circa Scientific, Inc. for the device "Cross Wise™ Multi-Use RF Adapter Cable". The FDA issued a decision of Substantially Equivalent on November 26, 2024. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Circa Scientific, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2024
Date Received
September 30, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Septostomy
Device Class
Class II
Regulation Number
870.5175
Review Panel
CV
Submission Type