CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM— 510(k) K033394
UnknownCordis Corp.
FDA 510(k) clearance K033394 for CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM, Unknown on 2003-12-22. Applicant: Cordis Corp.. Device class: 2.
Clearance details
- Applicant
- Cordis Corp.
- 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
- Special
- Location
- Warren, NJ, US
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- K253832 — Dilation Balloon Catheter
More clearances from Cordis Corp.
view all- K130981 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
- K112797 — POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
- K101651 — ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
- K082143 — MICRO GUIDE CATHETER XP
- K062798 — SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
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 →
Recalls naming K033394
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033394.
Data sourced from openFDA. This site is unofficial and independent of the FDA.