DeviceClearance

Affera Integrated Mapping System— 510(k) K262005

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K262005 for Affera Integrated Mapping System, Substantially Equivalent on 2026-08-21. Applicant: Medtronic, Inc.. Device class: 2.

Summary

Medtronic filed the Affera Integrated Mapping System under product code DQK, programmable diagnostic computers. The record doesn't describe the system beyond its name and that code.

Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).

Medtronic filed from Mounds View, Minnesota. FDA found it substantially equivalent 67 calendar days after receipt (June 15 to August 21, 2026).

Clearance details

Applicant
Medtronic, Inc.
Product code
Product code DQK
Device class
Class 2
Regulation
21 CFR 870.1425
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mounds View, MN, US
Download summary PDFView on FDA.gov ↗

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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 →

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