ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit— 510(k) K191060
Substantially EquivalentAcist Medical Systems, Inc.
FDA 510(k) clearance K191060 for ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit, Substantially Equivalent on 2019-07-18. Applicant: Acist Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Acist Medical Systems, Inc.
- Product code
- Code DXT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code DXT
view all- K252652 — Disposable Syringes with Accessories for Power Injectors (7+ models)
- K252638 — VeraPro S100 Multi-Use Syringe (018808) +4 more
- K252653 — ACIST Pro Diagnostic System (019304) +5 more
- K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
- K251788 — Extension tube
More clearances from Acist Medical Systems, Inc.
view all- K262115 — VueJect® Ultrasound Enhancing Agent Delivery System
- K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
- K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
- K193183 — ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
- K190473 — ACIST RXi System and Navvus II Catheter
Adverse events under product code DXT
product code DXT- Death
- 39
- Injury
- 242
- Malfunction
- 463
- Other
- 3
- Total
- 747
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.