510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073559Substantially Equivalent

18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula II

Edwards Lifesciences LLC, Midvale UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073559 is the FDA 510(k) clearance record for 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II, a class II device, cleared for Edwards Lifesciences Research Medical on under FDA product code DQR (Cannula, Catheter). FDA records list 165 510(k) clearances for EDWARDS LIFESCIENCES LLC, from to . As of , FDA records show 3 recalls naming K073559.

Clearance record

Decision date
Received
(43 days to decision)
Product code
DQR Cannula, Catheter
Regulation
21 CFR 870.1300
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences Research Medical 6864 S. 300 W., Midvale UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQR

Trailing 12 months

FDA records hold no clearances under product code DQR in the trailing twelve months.

FDA records show no clearances under product code DQR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DQR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260