VENTURE WIRE CONTROL CATHETER, MODEL WCC— 510(k) K042910
Substantially EquivalentVelocimed, Inc.
FDA 510(k) clearance K042910 for VENTURE WIRE CONTROL CATHETER, MODEL WCC, Substantially Equivalent on 2004-11-22. Applicant: Velocimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Velocimed, Inc.
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
Recent devices under product code DQY
view allMore clearances from Velocimed, Inc.
view allAdverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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 K042910
K-number listed on FDA's recall record- Z-3041-2018 — Vascular Solutions Venture Rx Catheter, 6F, resterilized.
- Z-2224-2017 — Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions (Models 5821 and 5822) may also be used for manual delivery of saline solution or diagnostic contrast agents
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042910.
Data sourced from openFDA. This site is unofficial and independent of the FDA.