DeviceClearance

EP-TRACER System— 510(k) K161245

Substantially Equivalent

Cardio Tek, BV

FDA 510(k) clearance K161245 for EP-TRACER System, Substantially Equivalent on 2016-08-05. Applicant: Cardio Tek, BV. Device class: 2.

Clearance details

Applicant
Cardio Tek, BV
Product code
Code DQK
Device class
Class 2
Regulation
21 CFR 870.1425
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ae Maastricht-Airport Limburg, NL
Download summary PDFView on FDA.gov ↗

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More clearances from Cardio Tek, BV

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Adverse events under product code DQK

product code DQK
Death
10
Injury
225
Malfunction
2,123
Other
2
Total
2,360

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 K161245

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 K161245.

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