ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS— 510(k) K040298
Substantially EquivalentAcist Medical Systems, Inc.
FDA 510(k) clearance K040298 for ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS, Substantially Equivalent on 2004-03-15. 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
- Special
- 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 →
Recalls naming K040298
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 K040298.
Data sourced from openFDA. This site is unofficial and independent of the FDA.