Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular— 510(k) K150262
Substantially EquivalentVolcano Corporation
FDA 510(k) clearance K150262 for Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular, Substantially Equivalent on 2015-04-03. Applicant: Volcano Corporation. Device class: 2.
Clearance details
- Applicant
- Volcano Corporation
- Product code
- Code DTK
- Device class
- Class 2
- Regulation
- 21 CFR 870.3375
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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- K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT) +4 more
More clearances from Volcano Corporation
view all- K210235 — Verrata PLUS Pressure Guide Wire
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- K202543 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K192886 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K190626 — SyncVision System
Adverse events under product code DTK
product code DTK- Death
- 208
- Injury
- 11,286
- Malfunction
- 3,002
- Total
- 14,496
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.