Venture 0.014 Catheter— 510(k) K182570
Substantially EquivalentVascular Solutions, LLC
FDA 510(k) clearance K182570 for Venture 0.014 Catheter, Substantially Equivalent on 2019-03-13. Applicant: Vascular Solutions, LLC. Device class: 2.
Clearance details
- Applicant
- Vascular Solutions, LLC
- 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
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code DQY
view allMore clearances from Vascular Solutions, LLC
view all- K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881) +8 more
- K230637 — Wattson temporary pacing guidewire (2250)
- K220647 — GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
- K221470 — Langston dual lumen catheter
- K212167 — R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.