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Parker Quality & Compliance

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510(k) clearance

DLP™ Coronary Ostial Cannulae

FDA 510(k) source

510(k) number
K263596
Applicant
Medtronic, Inc.
Decision date
Oct 29, 2026
Date received
Sep 30, 2026
Decision
Substantially Equivalent
Clearance type
Special
Product code
DWF
Device type
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class
Class II
Regulation
21 CFR 870.4210
Advisory committee
Cardiovascular
Statement or summary
Summary
Third party
N
Location
Brooklyn Park, MN, US