CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM— 510(k) K040413
UnknownCordis Europa, N.V.
FDA 510(k) clearance K040413 for CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM, Unknown on 2004-06-21. Applicant: Cordis Europa, N.V.. Device class: 2.
Clearance details
- Applicant
- Cordis Europa, N.V.
- Product code
- Code FGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Warren, NJ, US
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- K060302 — INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
- K043605 — INSCOPE 3-STAGE BALLOON DILATOR
- K032737 — CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA
Adverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
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.