DSP

System, Balloon, Intra-Aortic And Control

Product code
DSP
Device name
System, Balloon, Intra-Aortic And Control
Device class
Class 2
21 CFR
21 CFR 870.3535
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
162 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-03-26.

NumberDecision dateApplicantDevice nameSummary
K2505422025-03-26Arrow International, LLCAC3™ Range™ Intra-Aortic Balloon PumpPDF

1 summaries are archived here for direct download.

Official FDA classification page: DSP
Classification and pathway per current FDA publications. Data from openFDA (CC0).