Langston dual lumen catheter— 510(k) K221470
Substantially EquivalentVascular Solutions, LLC
FDA 510(k) clearance K221470 for Langston dual lumen catheter, Substantially Equivalent on 2022-06-17. Applicant: Vascular Solutions, LLC. Device class: 2.
Clearance details
- Applicant
- Vascular Solutions, LLC
- Product code
- Code DQO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
Recent devices under product code DQO
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- K254278 — Arterial Pressure Monitoring Set/Tray
- K250751 — DualView Catheter
- K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
More 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)
- K212167 — R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
- K212211 — Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
Adverse events under product code DQO
product code DQO- Death
- 35
- Injury
- 993
- Malfunction
- 1,772
- Other
- 5
- Total
- 2,805
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.