AMI™ Plasma Cartridge, AMI™
K-Number: K260613 · 2026-09-01
ApplicantSequitur Health Corp.
Decision Date2026-09-01
Product CodeJID
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
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.
Frequently Asked Questions
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.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.