CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set— 510(k) K151048
Substantially EquivalentBracco Injeneering
FDA 510(k) clearance K151048 for CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set, Substantially Equivalent on 2016-01-22. Applicant: Bracco Injeneering. Device class: 2.
Clearance details
- Applicant
- Bracco Injeneering
- 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
- Lausanne, CH
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.