CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER— 510(k) K071189
Substantially EquivalentCordis Europa, N.V.
FDA 510(k) clearance K071189 for CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER, Substantially Equivalent on 2007-05-16. Applicant: Cordis Europa, N.V.. Device class: 2.
Clearance details
- Applicant
- Cordis Europa, N.V.
- 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
- Special
- Location
- Roden, Drenthe, NL
Recent devices under product code LIT
view allMore clearances from Cordis Europa, N.V.
view all- K063563 — CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER
- K060302 — INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
- K043605 — INSCOPE 3-STAGE BALLOON DILATOR
- K040413 — CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
- K032737 — CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA
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.