VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER— 510(k) K072798
Substantially EquivalentAbbott Vascular-Vascular Solutions
FDA 510(k) clearance K072798 for VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER, Substantially Equivalent on 2008-01-31. Applicant: Abbott Vascular-Vascular Solutions. Device class: 2.
Clearance details
- Applicant
- Abbott Vascular-Vascular Solutions
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code LIT
view allMore clearances from Abbott Vascular-Vascular Solutions
view all- K090665 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19
- K090509 — FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER
- K081523 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
- K072708 — ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
- K080264 — MODIFICATION TO: FOX PLUS PTA CATHETER
Adverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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.