CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit— 510(k) K172455
Substantially EquivalentVolcano Corporation
FDA 510(k) clearance K172455 for CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit, Substantially Equivalent on 2017-10-25. 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
- San Diego, CA, US
Recent devices under product code IYO
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- 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 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 K172455
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 K172455.
Data sourced from openFDA. This site is unofficial and independent of the FDA.