CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM— 510(k) K062265
Substantially EquivalentSwiss Medical Care S.A.
FDA 510(k) clearance K062265 for CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM, Substantially Equivalent on 2006-12-26. Applicant: Swiss Medical Care S.A.. Device class: 2.
Clearance details
- Applicant
- Swiss Medical Care S.A.
- 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
- Flemington, NJ, US
Recent devices under product code IZQ
view all- K262115 — VueJect® Ultrasound Enhancing Agent Delivery System
- K252281 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- K251295 — ulrichINJECT CT Motion (XD 8000)
- K252689 — MEDRAD Centargo CT Injection System +4 more
- K241849 — MEDRAD Centargo CT Injection System +4 more
Adverse 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.