INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED— 510(k) K060302
Substantially EquivalentCordis Europa, N.V.
FDA 510(k) clearance K060302 for INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED, Substantially Equivalent on 2006-04-11. Applicant: Cordis Europa, N.V.. Device class: 2.
Clearance details
- Applicant
- Cordis Europa, N.V.
- Product code
- Code KNQ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5365
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roden, Drenthe, NL
Recent devices under product code KNQ
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view all- K071189 — CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
- K063563 — CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER
- 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 KNQ
product code KNQ- Malfunction
- 1,844
- Total
- 1,844
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.