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EZ Glide Aortic Perfusion Cannulae - OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233895

by Edwards Lifesciences

Identifiers

510(k) Number
K233895 FDA 510(k)
FDA Product Code
DWF FDA 510(k)
Models / Variants
EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA) FDA 510(k)
OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22) FDA 510(k)
EndoReturn Arterial Cannulae (ER21B and ER23B) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4210 FDA 510(k)
Regulation Number
870.4210 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

EZ Glide Aortic Perfusion Cannulae - OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22) by Edwards Lifesciences — Class II — FDA_510K…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Edwards Lifesciences

Sources (1)

  • FDA 510(k) K233895 24 fields · synced Jun 18, 2026