SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter— 510(k) K210647
Substantially EquivalentVascular Solutions, LLC
FDA 510(k) clearance K210647 for SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter, Substantially Equivalent on 2021-04-30. 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.