Acist Medical Systems
Acist Medical Systems holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2014, with 3 FDA device recalls on record.
Top product codes for Acist Medical Systems
FDA recalls by Acist Medical Systems
- Z-1161-2021 — ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.
- Z-0744-2016 — ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). To be used for the controlled infusion of radiopaque contrast media for angiographic procedures
- Z-1145-2013 — ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Acist Medical Systems
- K132474 — CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
- K020892 — ACIST GENTOO CONTRAST INJECTION SYSTEM
- K021015 — ACIST PLUS 4 ANGIOGRAPHIC CATHETER
- K991103 — MODIFICATION TO ACIST CL 100H
- K000013 — ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
- K993774 — ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
- K984058 — ACIST INJECTOR SYSTEM, MODEL CL100 H
Data sourced from openFDA. This site is unofficial and independent of the FDA.