ACIST INJECTOR SYSTEM, MODEL CL100 H— 510(k) K984058
Substantially EquivalentAcist Medical Systems
FDA 510(k) clearance K984058 for ACIST INJECTOR SYSTEM, MODEL CL100 H, Substantially Equivalent on 1999-02-11. Applicant: Acist Medical Systems. Device class: 2.
Clearance details
- Applicant
- Acist Medical Systems
- Product code
- Code IZQ
- 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
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- K241849 — MEDRAD Centargo CT Injection System +4 more
More clearances from Acist Medical Systems
view allAdverse events under product code IZQ
product code IZQ- Death
- 7
- Total
- 7
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.