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510(k) K232852

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable by Cross Vascular, Inc. — Product Code DXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2023
Date Received
September 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Cross Vascular, Inc.

  • K232809 — Cross Vascular RF Generator and Footswitch (optional accessory) (October 12, 2023)

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  • K211910 — Z-6 Atrioseptostomy Catheter (July 19, 2021)