DeviceClearance

Retrograde Coronary Sinus Perfusion Cannulae— 510(k) K253203

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K253203 for Retrograde Coronary Sinus Perfusion Cannulae, Substantially Equivalent on 2026-02-19. Applicant: Medtronic, Inc.. Device class: 2.

Summary

Medtronic's Retrograde Coronary Sinus Perfusion Cannulae are filed under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). The record gives no models or sizes.

Class II, 21 CFR 870.4210. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).

Medtronic filed from Mounds View, Minnesota. FDA found it substantially equivalent 146 calendar days after receipt (September 26, 2025 to February 19, 2026).

Clearance details

Applicant
Medtronic, Inc.
Product code
Product code DWF
Device class
Class 2
Regulation
21 CFR 870.4210
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mounds View, 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 →

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