Acist Medical Systems

FDA Regulatory Profile

Summary

Total Recalls
3 (1 Class I)
510(k) Clearances
21
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1161-2021Class IACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is aJanuary 22, 2021
Z-0744-2016Class IIACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) AutomaDecember 21, 2015
Z-1145-2013Class IIACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for theMarch 15, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_July 17, 2024
K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemDecember 17, 2020
K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterMarch 20, 2020
K190473ACIST RXi System and Navvus II CatheterSeptember 13, 2019
K191060ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2July 18, 2019
K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemJune 27, 2019
K171646ACISTCVi® Contrast Delivery SystemFebruary 16, 2018
K173063ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOctober 23, 2017
K172216ACIST RXi Mini SystemAugust 18, 2017
K132474CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETERJanuary 30, 2014
K093657ADAGIO RETRACTING ECG LEAD WIRESJanuary 15, 2010
K052744C2000 AUTOMATED MANIFOLD KITDecember 16, 2005
K040298ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITSMarch 15, 2004
K020892ACIST GENTOO CONTRAST INJECTION SYSTEMJanuary 27, 2003
K021015ACIST PLUS 4 ANGIOGRAPHIC CATHETERApril 26, 2002
K012983ACIST 4 FRENCH ANGIOGRAPHIC CATHETERMarch 13, 2002
K010390ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMSMarch 9, 2001
K991103MODIFICATION TO ACIST CL 100HMay 31, 2000
K000013ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000March 28, 2000
K993774ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOHDecember 7, 1999