510(k) K232852

Device: Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
Applicant: Cross Vascular, Inc.
510(k) number: K232852
Product code: DXF
Decision: Substantially Equivalent (SESE)
Decision date: 2023-10-12
Date received: 2023-09-14
Regulation: 870.5175
Classification name: Catheter, Septostomy
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: Yes

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