ACIST RXi System (016616); ACIST Navvus II Catheter (016675_— 510(k) K233904
Substantially EquivalentAcist Medical Systems, Inc.
FDA 510(k) clearance K233904 for ACIST RXi System (016616); ACIST Navvus II Catheter (016675_, Substantially Equivalent on 2024-07-17. Applicant: Acist Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Acist Medical Systems, Inc.
- Product code
- Code DXO
- Device class
- Class 2
- Regulation
- 21 CFR 870.2870
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code DXO
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view all- K262115 — VueJect® Ultrasound Enhancing Agent Delivery System
- K252638 — VeraPro S100 Multi-Use Syringe (018808) +4 more
- K252653 — ACIST Pro Diagnostic System (019304) +5 more
- K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
- K193183 — ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
Adverse events under product code DXO
product code DXO- Death
- 10
- Injury
- 156
- Malfunction
- 884
- Total
- 1,050
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.