DeviceClearance

DLP CORONARY OSTIAL PERFUSION CANNULAE— 510(k) K131269

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K131269 for DLP CORONARY OSTIAL PERFUSION CANNULAE, Substantially Equivalent on 2013-07-10. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant
Medtronic, Inc.
Product code
Code DWF
Device class
Class 2
Regulation
21 CFR 870.4210
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Minneapolis, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DWF

product code DWF
Death
106
Injury
386
Malfunction
2,323
Total
2,815

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 K131269

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 K131269.

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