OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION— 510(k) K063503
Substantially EquivalentMallinckrodt Inc., Liebel-Flarsheim Business
FDA 510(k) clearance K063503 for OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION, Substantially Equivalent on 2007-04-27. Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business. Device class: 2.
Clearance details
- Applicant
- Mallinckrodt Inc., Liebel-Flarsheim Business
- 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
- Special
- Location
- Cincinnati, OH, 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
More clearances from Mallinckrodt Inc., Liebel-Flarsheim Business
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.