DeviceClearance

FFR V2.5— 510(k) K170133

Substantially Equivalent

Philips Volcano

FDA 510(k) clearance K170133 for FFR V2.5, Substantially Equivalent on 2017-05-26. Applicant: Philips Volcano. Device class: 2.

Clearance details

Applicant
Philips Volcano
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
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

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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 →

Recalls naming K170133

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170133.

Data sourced from openFDA. This site is unofficial and independent of the FDA.