ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter— 510(k) K193183
Substantially EquivalentAcist Medical Systems, Inc.
FDA 510(k) clearance K193183 for ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter, Substantially Equivalent on 2020-03-20. Applicant: Acist Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Acist Medical Systems, Inc.
- Product code
- Code OBJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Eden Prairie, MN, US
Recent devices under product code OBJ
view allMore clearances from Acist Medical Systems, Inc.
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
- K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
- K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
Adverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
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 →
Recalls naming K193183
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193183.
Data sourced from openFDA. This site is unofficial and independent of the FDA.