Chrysalis Intelligence · Sponsors · Acist Medical Systems, Inc.

Acist Medical Systems, Inc.

Eden Prairie, MN, US · 6 510(k) clearances · 1 recalls (1 Class I)

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Total clearances
6
2020-03-20 → 2026-08-03
Last 12 months
3
Product codes
4
Most recent
2026-08-03
Name variants in FDA filings: ACIST Medical Systems, Inc. / Acist Medical Systems, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DXT Injector And Syringe, Angiographic Class II Cardiovascular 3 2026-05-13
IZQ — — — 1 2026-08-03
DXO Transducer, Pressure, Catheter Tip Class II Cardiovascular 1 2024-07-17
OBJ Catheter, Ultrasound, Intravascular Class II Cardiovascular 1 2020-03-20
Safety

Recalls (1)

Class I (serious)
1
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2021-01-22
DateSeverityStatusRecall # ProductCodeReason
2021-01-22 Class I Terminated Z-1161-2021 ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the AC… — Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 m…
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2026-08-03 K262115 VueJect® Ultrasound Enhancing Agent Delivery System IZQ — —
2026-05-13 K252653 ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable DXT Class II Cardiovascular
2026-05-13 K252638 VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) DXT Class II Cardiovascular
2024-07-17 K233904 ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ DXO Class II Cardiovascular
2020-12-17 K203004 ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System DXT Class II Cardiovascular
2020-03-20 K193183 ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter OBJ Class II Cardiovascular
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence