WIRE, GUIDE, CATHETER, MODEL QSW1000— 510(k) K002346
Substantially EquivalentMedtronic Ave, Inc.
FDA 510(k) clearance K002346 for WIRE, GUIDE, CATHETER, MODEL QSW1000, Substantially Equivalent on 2000-09-27. Applicant: Medtronic Ave, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Ave, Inc.
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minnetonka, MN, US
Recent devices under product code DQX
view allMore clearances from Medtronic Ave, Inc.
view all- K032768 — MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
- K030633 — MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT
- 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)
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.