PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM— 510(k) K983314

Substantially Equivalent

Nycomed Amersham Imaging

FDA 510(k) clearance K983314 for PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM, Substantially Equivalent on 1999-02-19. Applicant: Nycomed Amersham Imaging.

Clearance details

Applicant: Nycomed Amersham Imaging
Product code: Code IZQ
Advisory panel: Cardiovascular
Date received: 1998-09-21
Decision date: 1999-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZQ

product code IZQ

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.