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FDA 510(k)

AMI™ Plasma Cartridge, AMI™

N.º K: K260613 · 2026-09-01

SolicitanteSequitur Health Corp.
Fecha de decisión2026-09-01
Código de productoJID
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

AMI™ Plasma Cartridge, AMI™ is the device name listed in this FDA 510(k) record. The listed applicant is Sequitur Health Corp.. It received FDA 510(k) clearance on 2026-09-01 under 510(k) number K260613. The device is classified under product code JID. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AMI™ Plasma Cartridge, AMI™?

AMI™ Plasma Cartridge, AMI™ is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Sequitur Health Corp.. The 510(k) number is K260613.

When did AMI™ Plasma Cartridge, AMI™ receive FDA 510(k) clearance?

AMI™ Plasma Cartridge, AMI™ received FDA 510(k) clearance on 2026-09-01, under 510(k) number K260613.

Who is the listed applicant for AMI™ Plasma Cartridge, AMI™?

The FDA 510(k) record lists Sequitur Health Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMI™ Plasma Cartridge, AMI™?

The FDA product code for AMI™ Plasma Cartridge, AMI™ is JID.

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Fuente oficial

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