ACIST RXi Mini System
K-Number: K172216 · 2017-08-18
ApplicantAcist Medical Systems, Inc.
Decision Date2017-08-18
Product CodeDRQ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ACIST RXi Mini System is a medical device manufactured by Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-08-18 under approval number K172216. The device is classified under product code DRQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ACIST RXi Mini System?
ACIST RXi Mini System is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by Acist Medical Systems, Inc.. The 510(k) number is K172216.
When was ACIST RXi Mini System approved by the FDA?
ACIST RXi Mini System received FDA 510(k) clearance on 2017-08-18, under approval number K172216.
What company makes ACIST RXi Mini System?
ACIST RXi Mini System is manufactured by Acist Medical Systems, Inc..
What is the FDA product code for ACIST RXi Mini System?
The FDA product code for ACIST RXi Mini System is DRQ.
Other Devices by Acist Medical Systems, Inc.
K173063ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
K171646ACISTCVi® Contrast Delivery System
K190473ACIST RXi System and Navvus II Catheter
K191060ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
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.