R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire— 510(k) K212167
Substantially EquivalentVascular Solutions, LLC
FDA 510(k) clearance K212167 for R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire, Substantially Equivalent on 2022-02-09. Applicant: Vascular Solutions, LLC. Device class: 2.
Clearance details
- Applicant
- Vascular Solutions, LLC
- 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
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code DQX
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- K220647 — GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
- K221470 — Langston dual lumen catheter
- K212211 — Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
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.