MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT— 510(k) K030633
UnknownMedtronic Ave, Inc.
FDA 510(k) clearance K030633 for MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT, Unknown on 2003-09-02. Applicant: Medtronic Ave, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Ave, Inc.
- 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
- Santa Rosa, CA, US
Recent devices under product code FGE
view all- K260835 — ARCHIMEDES Biodegradable Stent (Medium)
- K253393 — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019
- K253832 — Dilation Balloon Catheter
- K251658 — Endoflux Biliary & Pancreatic Stent Sets
- K253987 — BARE Wireguided Balloon Dilation Catheter (1235)
More clearances from Medtronic Ave, Inc.
view all- K032768 — MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
- K030839 — MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
- K022026 — MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
- K014205 — MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
- K011080 — BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
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.