18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II— 510(k) K073559

Clearance details

Applicant

Edwards Lifesciences Research Medical

Product code

Code DQR

Device class

Class 2

Regulation

21 CFR 870.1300

Advisory panel

Cardiovascular

Date received

2007-12-19

Decision date

2008-01-31

Decision

Substantially Equivalent

Clearance type

Special

Location

Midvale, UT, US

• K131446 — INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES2013-10-28
• K051655 — ANGIODYNAMICS, INC., MICRO ACCESS KITS2005-09-12
• K030398 — CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-62212003-05-23
• K960098 — RMI INTERNAL MAMMARY ARTERY CANNULA1996-03-26
• K902674 — DATASCOPE ARTERIAL CANNULA W/ACCESS PORT1991-01-16

• K062429 — MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH2006-09-27
• K990396 — T-ANASTAFLO1999-10-01
• K991170 — RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-0141999-07-02
• K983791 — PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA1999-06-11
• K974259 — VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE1998-12-01

Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2080-2025 — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.Class I·Ongoing·Edwards Lifesciences, LLC·20250514
• Z-2081-2025 — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: NoClass I·Ongoing·Edwards Lifesciences, LLC·20250514
• Z-3034-2018 — Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.Class II·Terminated·SPS Sterilization, Inc·20180307

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073559.