VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM— 510(k) K111706
Substantially EquivalentVolcano Corporation
FDA 510(k) clearance K111706 for VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM, Substantially Equivalent on 2011-07-15. 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
- Special
- Location
- Rancho Cordova,, CA, US
Recent devices under product code IYO
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- K190626 — SyncVision System
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 →
Recalls naming K111706
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111706.
Data sourced from openFDA. This site is unofficial and independent of the FDA.