CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER— 510(k) K063563
Substantially EquivalentCordis Europa, N.V.
FDA 510(k) clearance K063563 for CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, Substantially Equivalent on 2007-03-07. 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
- Traditional
- Location
- Warren, NJ, US
Recent devices under product code LIT
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view all- K071189 — CORDIS AVIATOR PLUS 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.