IN VISION GOLD WITH SPIN VISION, MODEL 891 SV— 510(k) K052348
Substantially EquivalentVolcano Corporation
FDA 510(k) clearance K052348 for IN VISION GOLD WITH SPIN VISION, MODEL 891 SV, Substantially Equivalent on 2005-12-02. Applicant: Volcano Corporation. Device class: 2.
Clearance details
- Applicant
- Volcano Corporation
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Cordova,, CA, US
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Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.